clinical research site feasibility questionnaire

Feasibility Questionnaire: What Should You Know About and Include In It?

Clinical trial feasibility is a process to evaluate the possibility of conducting a clinical trial in a particular region, specific medical centers/site with an objective of optimum project completion in terms of timelines, targets and cost. This forms an integral and unavoidable step in beginning any clinical trial. Clinical trial feasibility is always facilitated by a well-structured feasibility questionnaire.

A feasibility questionnaire (FQ) is the set of questions prepared by a study sponsor or contract research organizations (CROs) to identify the potential and interest of a site/investigator to run clinical trial feasibility successfully.

Why feasibility questionnaire?

A detailed clinical trial feasibility assessment is an important step towards conducting a successful clinical study. Thus, a feasibility questionnaire becomes an important tool in ensuring successful project planning.

As per one analysis,

• 35% of delay in clinical trials occur due to patient recruitment,
• Early one-fifth investigators do not enroll any patients and
• About one-third enroll only 5% of evaluable patients.

This puts a lot of burden on project costs, timelines, and other investigators who may be performing satisfactorily.

This is where a well-administered feasibility questionnaire can help avoid such issues.

• The clinical trial feasibility questionnaire identifies these challenges and helps in deciding to work efficiently with different countries and sites with their respective challenges.
• Clinical trial feasibility questionnaires help in identifying region-specific or even institution-specific practices that can have an impact on overall study completion.
• Asking questions can inform the design and implementation, avoiding major downstream and operational problems.
• It’s an efficient way to collect certain types of information for screening purposes and as the basis for a discussion.
• The benefits of a proper assessment are realized during the execution of the trial.
• With proper planning, unnecessary protocol amendments, delays due to recruitment challenges, and operational problems can be avoided.
• If the site thinks or realizes it is not a good fit, everyone saves time.
• Data collected from sites from prior projects in the database helps to find the capability of sites and eliminates the need for sites to complete redundant information again.

How does an FQ help an investigator/site?

An FQ is not only a pragmatic approach for a sponsor, but it also helps the investigator and his/her staff to understand and accept the

• Investigational nature of the study and the investigational product.
• Expectations to access an appropriate subject population.
• Roles and obligations as defined in the study contract and protocol.
• Applicable regulatory requirements and responsibilities to the IRB/EC.
• Content, maintenance, and retention of source documents, records, and Investigational products .

In order to determine the best design for your FQ, it is important to consider the type of feasibility study that you intend to perform.

Learn about clinical trial feasibility – Important tool before you conduct a clinical trial

Types of Feasibility studies

Program level feasibilities.

These feasibilities are broad and are aimed towards finding the prevalence of particular diseases or conditions in a particular region and hence include clinical and epidemiological information. e.g. a program on antibacterial in a variety of infections.

Study level feasibilities

Study level feasibilities are more customized towards assessing whether a particular clinical study can be conducted in a country or region.

e.g: an antibacterial in the skin and soft tissue infections.

Click here to learn about Country Level Clinical Trial Feasibility: Top 7 Key Areas To Explore

Site or Investigator level

This is micro-feasibility conducted to decide whether to work with an investigator, identifying challenges and probable solutions as selecting the right investigator/site is of paramount importance.

e.g: Accessing the safety and efficacy of a drug at a site or multiple sites.

Web-based questionnaire

Web-based questionnaires are generally applied when the sponsor has multiple centers to conduct clinical trial feasibility. It’s also helpful in epidemiological studies and survey studies.

• Web-based questionnaires with branching questions can efficiently collect the required information.
• It helps the CRO/sponsor when there are multiple regions, centers, sites, and investigators.
• The industry has access to many applications that can quickly set up a web-based system.

Advantages of web-based feasibility questionnaire

• The online system with the audit trail, reporting tools, electronic tracking, and quick setup and response.
• Immediate response to potential collaborators allows tremendous savings on time and resources in decision-making and trial setup.

Credevo offers a well-structured, yet customizable, web-based system that can cater to your specific study needs

Now, depending upon the type of your feasibility, you can set objectives for your FQ to achieve.

Get a FREE consultation for your clinical trial, set of recommended questions for your FQ, or trial of the Credevo Web-Based feasibility system. See details below (including a link to download a sample FQ format)

What are the FQ objectives?

In most of the feasibility conducted at the sites/investigator level, the objective of the FQ prepared by any sponsor/CRO may be to

• Determine the site/Investigator’s level of interest in the study.
• Determine the readiness of the site/investigator to fulfill project expectations.
• Obtain statements and commitments.
• Collect information useful in changing or managing the study.
• Help the site think through operational aspects, such as subject recruiting.
• Finding whether the disease under study is relevant to the patient population.
• Assess anticipated regulatory, ethical challenges, and general timelines for study approval and site start-up.
• Evaluate the overall commitment of potential partners- country offices, CROs, sites towards completion of the program.

It is also possible to add/modify/delete more points in this list and make the objectives more relevant to the project. The responsibility to set the objectives of FQ rests with the sponsor and trial manager.

Having set the objectives, the next step is to consider import points, formats, DOs, and DONTs of FQ.

Designing FQ

Format of feasibility questionnaire (fq).

Format of a questionnaire generally includes sections pertaining to

• Introduction,
• Summary of study,
• Contact address,
• Conclusions.

Important Points

Before designing an FQ, here are some points to be considered

• The language of the questionnaire should be considered based upon the region and site/investigator.
• The purpose of a questionnaire should be clearly described.
• FQ should be necessarily sufficient, clear, and unambiguous to the purpose.
• Straightforward, adequate options, and space for the answer.
• Allow a broad range of answers and not reveal the “right” answer.
• Accommodate the characteristics of different types of sites.
• Generate answers that the sponsor can interpret, score, and validate for predictive ability.

Additionally, there are a few suggestible Do’s and Dont’s. These are as follows

• A compact and easy questionnaire.
• Elicit comments and allow space to elaborate.
• A detailed summary of the study and sponsor.
• Allow skipping on questions particularly in the electronic questionnaire.
• If web-based FQ, allow sites to elaborate on the information, as it may not be easily answered by using a single number in the data entry field.
• Giving sites the time they need to get the best possible answers.
• Providing sponsors contact information.

Dont’s

• True/false, multiple-choice, and numeric answers format as they do not reveal the site’s thought processes.
• Sloppy questionnaires with typos, ambiguous questions, and inadequate space for answers.
• Asking the same question in two different ways and have all fields marked as required.
• Assuming that there’s only one PI at a site.
• Sending out a survey that can’t be printed.

Having considered all these factors, now one is ready to design and administer a well-structured FQ.

Download Feasibility Questionnaire Format From our experience in conducting many clinical trial feasibility and suggestions from industry experts, we have identified a list of many questions that can be helpful in designing your feasibility questionnaire. We’d love them to be used in your clinical trial feasibility. Click here to download feasibility questionnaire format for conducting clinical trial feasibility

Click here for more useful links

• Country Level Clinical Trial Feasibility: Top 7 Key Areas To Explore
• Clinical Trial Feasibility – Important Tool Before You Conduct Clinical Trial
• Finding Clinical Trials to Work Upon as Clinical Investigator
• Critical Factors in Selecting a CRO: from Frost & Sullivan white paper

Try web-based feasibility for your clinical trial

• https://firstclinical.com/journal/2009/0911_Site_Questionnaires.pdf
• http://store.centerwatch.com/pdfs/samples/sopsp14_ss401.pdf
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146075/

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Clinical trial site feasibility, definition of site feasibility.

For clinical trials conducted at various research sites, the selection of appropriate sites for conducting the research sets the foundation for a successful trial. Site feasibility describes the process of verifying that prospective sites are capable of running that particular study, with adequate resources, facilities, knowledge, and personnel.

Factors that impact site feasibility in clinical trials

Many factors play into whether or not a site is feasible, including its geographic location, availability and training level of personnel, infrastructure and equipment, prior experience in similar studies/therapeutic areas, safety and compliance records and SOPs, and access to relevant patients. A thorough evaluation of these factors must be conducted before a clinical trial agreement ( CTA ) is signed with the site in order to ensure that trial operations are left in capable hands.

The importance of site selection in clinical trials

Selecting high-performing sites is part of effective clinical trial design, and carries significant implications for timely completion and success of clinical trials. Site feasibility studies are an essential step in the site selection process, and help sponsors determine the ability of a potential site for hosting a given clinical trial by evaluating the suitability of the site’s infrastructure, staff, and facilities against criteria based on the specific needs and objectives of the trial.

It’s particularly important to consider the desired study population, and whether the site has access to eligible patients. For studies involving in-person study visits, the proximity of patients to the study site should be taken into account in order to ensure recruitment targets can be met.

What is a clinical trial site feasibility study?

A comprehensive investigation into all aspects related to a prospective site’s potential to fulfill the research needs of the trial is known as a 'site feasibility study'. A site feasibility study will usually cover a wide variety of aspects about the site, and is designed to provide the sponsor with a clear idea of whether the site may be capable of conducting the clinical trial according to protocol.

It also allows sponsors to foresee and predict potential challenges that may arise during the course of the study. For instance, it could help sponsors anticipate issues with recruitment or retention of patients in a specific geographical area, or identify sites which may need additional training or support on a certain software tool. Ultimately, site feasibility studies help sponsors make informed decisions about where to conduct their clinical trials for optimal success.

Factors to consider when conducting a site feasibility study

Multiple factors are taken into account when determining site feasibility, and can include:

• Geographic location
• Qualifications & experience level of investigators
• Availability and capabilities of staff (including up-to-date training records)
• Compliance with legal regulations pertaining to conducting clinical trials in the local jurisdiction/country
• Physical resources like medical supplies and equipment, clean and well-maintained facilities
• Specialized skills or medical knowledge, as required by individual studies
• Assessment of the available participant demographic against the trial’s basic eligibility criteria , such as age, ethnicity, and principal diagnosis
• Local regulations, which may influence cost and timelines
• Potential cultural subtleties and the familiarity of the site with these
• Evaluation of overall safety standards at each prospective location

Steps involved in conducting a site feasibility study

The steps involved in carrying out a site feasibility study can vary depending on the nature of the particular trial being conducted as well as other factors related to the location and the prospective site. Generally speaking, key steps include:

• Identifying a wide variety of potential sites
• Collecting detailed information about each site via site feasibility questionnaires (SFQ; see next section) from each investigator or facility being assessed
• Compiling results to narrow down the list to a smaller subset of high-potential sites
• Communicating with those sites for further clarifications, and likely conducting a site visit
• Agreeing on terms through a clinical trial agreement.

We have written a detailed article on the steps sponsors can take to optimize site selection .

Site feasibility questionnaire (SFQ): An invaluable yet limited tool for site selection

A specific tool often used to facilitate site selection is the site feasibility questionnaire (SFQ). An SFQ is a survey designed by the sponsor which has the aim of collecting information about potential research sites in a consistent and organized manner. This makes it easier to quickly identify sites with the highest potential in consideration of the specific needs of the trial at hand.

The SFQ typically consists of multiple-choice (or otherwise constrained) questions covering topics such as investigator qualifications, staff training and capabilities, performance history, facility and equipment availability, previous experience working on similar clinical trials, etc. It can be customized by the sponsor to reflect the protocol and requirements of the particular clinical trial being conducted. The responses obtained via SFQs can provide critical - although somewhat superficial - insights into how suitable a certain site may be for hosting the clinical study. As we will discuss next, it’s usually necessary to visit the site or at least communicate directly with the principal investigator in order to go beyond the information provided in the SFQ - which is self-reported - in order to verify that the reality of the site’s operational capacity matches that stated on paper.

Visit the site in-person to verify feasibility

Determining the feasibility of a site you haven’t worked with before is not as simple as sending out the SFQ. Since responses to SFQs are self-reported, there is a tendency for sites to exaggerate - particularly when it comes to recruitment capabilities. Other things that can’t be accurately or completely captured through surveys include the cleanliness of facilities and how presentable they are to patients, verification of staff training records, and availability of medical supplies, to name a few. For this reason, conducting an in-person site visit is usually an essential prerequisite step before signing a CTA with any site. In this visit, the sponsor (or a representative such as the clinical research coordinator or monitor) has the opportunity to verify information reported in the SFQ first-hand; discuss and clarify any doubts with the site’s investigator and staff; inspect facilities, training records, SOPs, and supplies; and establish a personal connection, which may improve the communication between the sponsor and the site. It is important that the sponsor feel confident in the site’s ability to conduct the trial smoothly, and the CTA should clearly lay out all aspects of the working relationship, with doubts and specifics previously agreed upon through transparent and effective dialogue.

Other potential difficulties in determining clinical trial site feasibility

Another potential difficulty arises in international studies requiring sites in different countries, as applicable regulations as well as cultural nuances vary widely between regions and can have significant impacts on trial operations. Language barriers represent another issue to overcome, as it is absolutely essential that both parties clearly understand the details of the arrangement as laid out in the CTA. In such cases, best practice may involve contracting a local representative who is well-versed in clinical research in the destination country, but who is also familiar with the internal goals and protocols of the sponsor organization.

Effective site selection involves thorough feasibility analyses of potential sites as well as open dialogue and two-way communication between the site and the sponsor organization. By closely examining all relevant features and capabilities of prospective sites, sponsors can increase the chances of a successful trial and minimize risks, delays, and costs associated with shortcoming in meeting recruitment targets, miscommunications and misunderstandings, or an incapability to conduct the trial smoothly and comply with regulations.

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Site Feasibility

Find the most qualified sites for your clinical trial faster by leveraging data from the world’s largest repository of historical performance records for sites and investigators.

Dramatically speed clinical trial site selection—and your path to market.

If you’d like to overcome the obstacles to finding and engaging the world’s most highly qualified clinical trial sites, consider WCG’s Site Feasibility service.

WCG Site Feasibility helps you rapidly identify sites specifically qualified for your study, because we recruit using sites’ historical performance—enrollment, experience and results—in clinical trials.

It adds up to significantly faster site selection, study activation and time to market.

WCG’s Site Feasibility helps you activate productive sites faster than any other strategy.

If your goal is rapid, insightful selection of high-quality sites for your clinical study, WCG offers compelling benefits you won’t find elsewhere.

Site Rankings

WCG’s platform allows you to precisely rank more than 220,000 investigators in 130 countries based on 20 years of historical participant recruitment rates, compliance history, therapeutic specialization, study experience and results.

Site Surveying

WCG’s Site Feasibility clinical trial site surveying tool helps you achieve extraordinary accuracy and cooperation from leading sites—ensuring faster qualification and a smoother, more productive relationship throughout the study.

Flexible Functionality

Depending on your needs, the site feasibility service can be acquired as a stand-alone application that you manage or provided as a service with survey development assistance and call-center follow-up to optimize response rates.

WCG helps you find, choose and activate the world’s most qualified sites globally.

WCG’s Site Feasibility service gives you access to the largest repository of historical performance records for sites and investigators. This helps you identify sites most likely to generate the number and quality of participants you seek, as well as those that offer desired therapeutic competency and the clinical integrity and efficiency your study requires.

In addition, the WCG Site Feasibility service uses a configurable digital tool that allows for more rapid development of clinical site surveys, more precise information results matched to your study, easier-to-answer surveys and greater, faster cooperation from potential sites.

Perhaps even more importantly, this surveying tool permits close, step-by-step visibility of the entire qualification process, allowing you to manage and expedite it in real time.

Ultimately, the WCG capability means you work with fewer, more effective sites, study results are more reliable, costs are lower and you stay on schedule—often shaving months off the clinical trial cycle.

Benchmark site performance for your study

Interested to see how the investigators in your current or planned studies match up against the historic performance of all available investigators for the therapeutic area of the study?

Complete the form to schedule a consultation with WCG. We’ll share benchmark data, analyze your results, and share some of the common practices of top performers.

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New Research Statement Recommends Streamlining and Standardizing Clinical Trial Site Feasibility Assessments

Feasibility assessments for clinical trials are conducted to establish that prospective trial sites can safely and effectively meet study goals and protocol requirements; however, a new research statement from ASCO asserts that current standards are “costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness.” These deficiencies ultimately result in fewer patients with timely access to clinical trials and delays in advancing novel safe and effective treatments.

The research statement, which was published in JCO Oncology Practice , 1 provides concrete recommendations to improve the effectiveness and efficiency of the feasibility assessment process to ensure that more trial sites and patients can participate in oncology clinical trials. These recommendations also help address a goal established in ASCO’s Road to Recovery Report to simplify, streamline, and standardize clinical trials.

The following recommendations were developed through an ASCO task force and incorporate feedback from stakeholders including trial sites, biotech-pharma sponsors, and contract research organizations. The recommendations were approved by ASCO’s Board of Directors.

Streamlining Feasibility Assessments

During the typical feasibility assessment process, sponsors and contract research organizations assess the ability of a site to conduct clinical trials and implement specific trial protocols. The feasibility assessment process typically includes completion of a comprehensive and lengthy site feasibility questionnaire and an in-person prestudy site visit prior to selecting the site for a trial.

“Stakeholders who participated in this initiative described existing site feasibility methods as burdensome, inefficient, time-consuming, redundant, and resource intensive. They also reported that the process causes delays in time to enrollment and affects the capacity for sites to participate in clinical trials, particularly smaller research programs with limited resources and infrastructure,” the authors write.

ASCO recommends the implementation of a streamlined and uniform feasibility assessment process for use by all trial sponsors and contract research organizations. Feasibility assessments should be conducted in one of the three ways: (1) a short feasibility questionnaire and a prestudy site visit; (2) a long feasibility questionnaire alone (no prestudy site visit); or (3) a prestudy site visit or teleconference alone (no feasibility questionnaire). All stakeholders identified benefits with the recommended process changes, including time savings, expedited start-up, reduction in personnel resources, and cost savings.

In addition to recommended process changes, the research statement also outlines best practices for sponsors, contract research organizations, and trials sites to adopt to improve efficiencies throughout the feasibility assessment process. For example, each organization should consider establishing standard operating procedures, designating a single point of contact, and conducting as much of the process as possible remotely. Trial sites should also consider maintaining a standardized site capabilities document to share with sponsors and contract research organizations.

Minimizing Questions

Questions asked through feasibility questionnaires and prestudy site visits are often redundant and highly variable across sponsors and contract research organizations. ASCO recommends sponsors and contract research organizations standardize feasibility assessment questions with common nomenclature, questions, and response options. Feasibility assessment questions should also be kept to the minimum necessary (ie, need-to-know) and focus on two factors: (1) site capability to conduct clinical trials and (2) specific protocol feasibility.

Minimizing and standardizing feasibility assessment questions would save sites a significant amount of time and effort and would help them respond with accurate and consistent information.

Centralizing Information Exchange

ASCO recommends all sites, trial sponsors, and contract research organizations use a universally accessible and accepted database and portal to centralize feasibility assessments, improve efficiencies, and expedite clinical trial start-up. The database should be a Web-based portal that can integrate as seamlessly as possible into clinical and research staff workflows.

The research statement acknowledges existing portals have limitations and/or are not widely used, and competition among sponsors, contract research organizations, and vendors might make agreement on a single portal unlikely in the near future. In the absence of a portal, sites, sponsors, and contract research organizations should use a universal and standardized site profile and capabilities form to more efficiently share information.

“All stakeholders stand to benefit from implementing these recommendations,” the authors write. “To have meaningful impact, adoption and consistent execution of these recommendations across all trials, sponsors, contract research organizations, and sites are essential. 

1. Kurbegov D, Hurley P, Waterhouse DM, et al: Recommendations to streamline and standardize clinical trial site feasibility assessments: An ASCO research statement. JCO Oncol Pract 17:41-51, 2021 .

© 2021. American Society of Clinical Oncology. All rights reserved.

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Toward Optimizing Site Feasibility Assessment For Clinical Trials

Contributed Commentary by Zaneta Szkarlat, PhD and Dave Li MD, PhD., KCR Consulting 

August 18, 2023 | Selecting appropriate sites is one of the most crucial factors for determining successful completion of a clinical trial. It is important to ensure that potential trial sites have the capability to meet the protocol requirements and the capacity to deliver the study objectives in a safe and efficient manner ( DOI: 10.1200/OP.20.00821 ). Sites that are unable to successfully recruit enough patients not only extend the enrollment period but also impose an unnecessary economic burden. Furthermore, sites lacking adequate experience could be more prone to protocol deviations and may lead to low-quality data, requiring additional training, on-site visits, and increased queries for clarification. All these factors contribute to increased costs and prolonged study duration ( DOI: 10.1136/bmjopen-2016-014796 ). In this article we explore some practical strategies toward optimizing the site feasibility assessment. 

An important initial step to achieve successful site selection is to develop an adequate study-specific feasibility questionnaire. Questions should be carefully chosen to cover the most relevant aspects of study design: access to patient population, enrollment projections, investigator and site staff experience, available equipment, possibility to perform protocol required procedures, competing trials, and site interest. 

The American Society of Clinical Oncology recently issued recommendations for enhancing site feasibility assessments. They suggest minimizing and standardizing questions when evaluating a site's suitability for a trial to facilitate and accelerate the process. It encourages investigators to complete the questionnaire and eliminates delays resulting from their constrained availability. Questions should be standardized with common nomenclature and reduced to the minimum required for preliminary site selection. The primary focus is aimed on two key factors: the site's capacity to carry out clinical trials, and the feasibility of implementing the specific protocol. More detailed information is assumed to be collected during pre-study visit; therefore, it is important to avoid requesting redundant data. Implementing standardization decreases variability among assessments, streamlines the process for sites, and facilitates prompt responses with precise and consistent information ( DOI: 10.1200/OP.20.00821 ). 

When developing the feasibility questionnaire, it is anticipated that the collected data will be synthesized and analyzed in a systemic manner, and therefore it can be conclusively reportable. It is advisable to avoid open questions whenever possible, as it can complicate the analysis process. 

To ensure an accurate assessment, it is necessary to provide sites with detailed protocol requirements and inclusion/exclusive criteria per protocol. This enables them to thoroughly evaluate their capabilities and provide precise and accurate responses to the questions. 

Under certain circumstances, waiving the completion of the questionnaire is worth considering: for instance, if the site is well-known to the sponsor and has similar exposure from other trials. In such cases, collecting additional data may be redundant and create unnecessary burden for the site. 

The most efficient method of collecting feasibility data is using an electronic platform where the site information is directly stored. This approach enables real-time analysis, accurate reporting, future retrieval, and supporting decision making. Furthermore, it facilitates the creation of a site-specific database and building working relationships for future collaborations.  

There are multiple options for data input: it can be done by the principal investigator, the study coordinator or collected during the interview by the feasibility process lead and subsequently entered the system. 

Collected data should be extracted from the system and presented clearly allowing for the review of site capabilities. Integral in this process is the critical analysis of obtained data to emphasize the site information deemed as the most important for the decision-making in the site selection process. Predictive analysis can be applied to streamline the assessment process. Scores are assigned or determined by site-specific factors or features from the questionnaire with relative importance according to study protocol and designs. This allows for the ranking of sites, enabling the selection of the most suitable ones.  

Overall ranking could be supported by artificial intelligence algorithms using machine learning or deep learning. These algorithms can be trained using data from past successful studies, enabling them to forecast the future performance of the sites for a new study objectively. Furthermore, the feasibility assessment algorithm could be reiterated for performance improvements with additional or substituted feature extractions for further optimization with expanded training datasets per specific study design in protocol.  

Multiple factors or features are associated with decision making in clinical study site selections which can easily exceed the human cognitive capability. It is expected that the comprehensive data analysis could ideally be fully automated with accumulative multiplexed data using an advanced deep learning approach in neural networks which the data representations could be more informative and meaningful because the deep leaning algorithms have multiple successive layers of data representation via transformations with a backpropagation workflow for adjusting the weights of each layer for a given task toward expected outputs.  

We perceive that the most important criteria for decision during site selection are usually enrollment projections, due to their significant impact on study completion. The other crucial aspects that require attention include the experience and capability of investigators/sites to perform study procedures.  

For example, gene therapy trials where oncolytic virus is delivered by intratumoral injection, require experience in handling GMO (genetically modified organisms) and collaboration of multidisciplinary team, including medical oncologist, radiologist, surgeons. All the above-mentioned aspects should be analyzed. In this example, ongoing competing trials, which are usually treated as negative factor for accrual, can be advantageous in the case of the highly complex protocols for intratumoral injection indicating the site has experience in the field from exposures to similar studies. 

Feasibility assessments for site selection are complex, consisting of multiple steps and affected by a variety of factors depending on the study design and objectives. Optimizing the process, using an automated platform for data collection and real-time analysis facilitated by AI tools may enhance the chances for successful study execution that is on time, on budget, and delivers desirable outcomes. 

Zaneta Szkarlat, PhD Dr. Szkarlat is a Consultant at KCR with over 5 years of experience within the clinical research area. Her professional expertise revolves around various aspects of clinical trials, with a strong focus on the feasibility process. She has a solid scientific background derived from obtaining PhD in Biotechnology complemented by experience in biotechnology industry. She can be reached at [email protected].   

Dave Li, MD, PhD Dr. Li is a principal consultant and Clinical Research Physician with the KCR Consulting. He is a medical oncologist and regulatory scientist, and an expert in molecular medicine, immuno-oncology, and clinical informatics. He was on the faculty of Johns Hopkins Medicine and served as a medical officer with the US/HHS FDA before joining KCR. He obtained his medical degree from the Sun Yat-sen University, and MSc/PhD at the University of Texas M.D. Anderson Cancer Center at Houston, Texas. He can be reached at [email protected].   

Clinical trial feasibility assessment and start-up tool (CTFAST).

e14089 Background: Selecting the right clinical trials for patients remains a challenging job. The better the match between a clinical trial and the target patient population before conducting a study, the more likely the study will successfully reach the target goal of recruitment. We developed a feasibility assessment scoring system based on our vast clinical research experience, managing multiple sites across a large health system, applicable to oncology as well. Methods: Our feasibility team (FT) is responsible for identifying clinical trials and determining if they are an appropriate match for our institution and unique patient population. Once a potential trial is identified, FT performs a feasibility assessment of the research protocol to determine the resources required to conduct the trial. We developed a Clinical Trial Feasibility Assessment & Start-up Tool (CTFAST) to help sites streamline their feasibility assessments and track their trial through the start-up phase. With CTFAST a feasibility score is generated based on the cumulative value assigned to several items such as: sponsor, study type, pharmacokinetic studies, trial phase, etc. A feasibility scale is assigned as follows: > 25 – Accepted; 15-25 – On Hold; < 15- Rejected. Accepted studies are assigned a color coded priority track (fast, intermediate, routine), that allows team members to prioritize their studies accordingly. Once a study is accepted, the study is processed for enrollment. Results: CTFAST has increased productivity and clinical trial revenues by 40%. CTFAST allows for early identification of bottlenecks in workflow, thereby improving outcomes. By appropriately matching of clinical trials to our site, enrollments increased by 50% with an expanded clinical trial portfolio across 9 different departments. Study start-up times have been reduced to a minimum of 21 days and the use of time & effort has been optimized. Conclusions: CTFAST is replicable across all clinical trial sites and provides an expansive and critical feasibility analysis that is not attainable by traditional querying of investigators and questionnaires. It is an excellent work flow improvement tool as it critically analyzes all aspects of a study, prior to enrollment. When conducting an effective feasibility analysis the clinical trial site can optimize clinical trial outcomes.

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Transforming the site feasibility assessment process for oncology clinical trials.

e14092 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and no-value steps that impact research site resources and clinical trial participation. This project sought stakeholder feedback on recommendations to transform industry sponsor and contract research organization (CRO) processes for evaluating sites for trials. Methods: An ASCO task force developed recommendations to improve the feasibility assessment process and standardize and centralize questions and forms. A survey was conducted with sites, industry trial sponsors, and CROs to obtain feedback and assess buy-in for the recommendations. Results: Respondents were from 28 oncology research sites (19 academic, 9 community-based), 8 sponsors, and 4 CROs. All stakeholders agreed that the current process is burdensome (93% sites, 90% sponsors, 100% CROs), standardization will improve the process (86% sites, 87% sponsors, 75% CROs). All agreed a centralized portal will reduce burdens (93% sites, 100% sponsors, 75% CROs) and expedite trial start-up (89% sites, 100% sponsors, 75% CROs). Site certification was a viable option for sites (86%) and CROs (75%), but less so for sponsors (57%). Most respondents preferred a two-tier model: 1) a short site questionnaire followed by a pre-study visit for new interactions, and 2) only a pre-study site visit or a teleconference if there is an existing relationship. The greatest benefits were time savings, expedited start-up, reduction in personnel resources, and cost savings. The greatest barriers to adoption were buy-in and alignment from sponsors/CROs and insufficient information about site or protocol. Top predictors of a site’s success on a trial were physician engagement, available patients, and site experience. Conclusions: Site feasibility assessments are important for all stakeholders to establish trial suitability. However, current methods impose tremendous burdens on site resources (reported by authors elsewhere). While this sample is limited, the proposed process and standardization changes show promise to reduce burdens and costs for all stakeholders and expedite patient enrollment onto clinical trials.

Authors’ Responsibilities and Ethical Publishing

The International Cardiovascular Forum Journal requires authors to abide by the following guidelines:Manuscript: The corresponding author declares that the manuscript has not been published and is not under consideration elsewhere.Authorship: The corresponding author takes full responsibility for the list of authors.  Any modification to the author list including order and composition can only be approved by the Editor-in-Chief following signed agreement from all the authors listed on the original submission.Ethics: The corresponding author states that the material presented has been obtained with the approval of all appropriate animal and/or human ethics committee(s).Permissions: The corresponding author on behalf of all authors confirms whether explicit written consent to publish has been received from any people described, pictured, or recorded and that formal copyright clearance is obtained to publish any video or audio recordings.Registration of Clinical Trials: Prospective registration of any clinical trial in a publically accessible database is a requirement for later publication of such trials in ICFJ. In exceptional circumstance if the trial is not registered, or is registered retrospectively, the reasons for this must be given.Competing Interests: All authors must declare all relevant competing interests (financial, or non-financial, professional, or personal) and state all funding sources.Attribution: The corresponding author accepts full responsibility for the accurate citation and acknowledgement of any material reproduced from other publications including the author’s own prior work.It is incumbent upon the corresponding author to consult the Editor-in-Chief should there be any variance of the above. The Editor-in-Chief retains the right to retract any submission found to be in breach of the above guidelines.  

Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study

Abstract Background Training is essential before working on a clinical trial, yet there is limited evidence on effective training methods. In low and middle income countries (LMICs), training of research staff was considered the second highest priority in a global health methodological research priority setting exercise. Methods We explored whether an enhanced training package in a neonatal feasibility study in Kenya and India, utilising elements of the train-the-trainer approach, altered clinicians and researchers’ clinical trials knowledge. A lead “trainer” was identified at each site who attended a UK-based introductory course on clinical trials. A two-day in-country training session was conducted at each hospital. Sessions included the study protocol, governance, data collection and ICH-Good Clinical Practice (GCP). To assess effectiveness of the training package, participants completed questionnaires at the start and end of the study period, including demographics, prior research experience, protocol-specific questions, informed consent and ICH-GCP. Results Thirty participants attended in-country training sessions and completed baseline questionnaires. Around three quarters had previously worked on a research study, yet only half had previously received training. Nineteen participants completed questionnaires at the end of the study period. Questionnaire scores were higher at the end of the study period, though not significantly so. Few participants ‘passed’ the informed consent and ICH-Good Clinical Practice (GCP) modules, using the Global Health Network Training Centre pass mark of ≥ 80%. Participants who reported having prior research experience scored higher in questionnaires before the start of the study period. Conclusions An enhanced training package can improve knowledge of research methods and governance though only small improvements in mean scores between questionnaires completed before and at the end of the study period were seen and were not statistically significant. This is the first report evaluating a clinical trial training package in a neonatal trial in LMICs. Due to the Covid-19 pandemic, research activity was paused and there was a significant time lapse between training and start of the study, which likely impacted upon the scores reported here. Given the burden of disease in LMICs, developing high-quality training materials which utilise a variety of approaches and build research capacity, is critical.

Patients Driving the Clinical Trial Designs – Democracy in Clinical Research

Background: Many of the clinical trials remain inefficient owing to the low retention rate, and an impact on the power of the study. In addition, regulatory bodies recommend including the patients’ experience, especially, patient-reported outcomes, while making clinical decisions, and approvals. Introduction: Patient centricity has reached the stage where patients are both willing and required to participate in clinical trial designs, regulatory review and experts on other panels. Efforts are being made in the right direction and there are multiple aspects that have been or are being addressed. Objective: The current article focuses on how to include patients in clinical trial designs, the benefits, challenges, and solutions. This means patients who were merely the participants until now, they will be the drivers of trials now, and hence the clinical trials will be more efficient and productive. Key Findings: There is a drive to enhance patients’ participation in clinical trial designs, especially, visits, efficacy outcomes and their expectations with the treatment. Patients want to remain informed, right from before participation to the completion of the trial. Patients are now an important part of regulatory review, as apparent from recent initiatives by the FDA and EMA. This will enhance patients’ awareness, and bring ownership and transparency. Various patient organizations, advocacy groups have made some great suggestions and taken initiatives in this direction. Clinical Trials Transformation Initiative, European Patient’s Academy on Therapeutic Innovation, and Patient- Centered Outcomes Research Institute are a few key initiatives. However, there is a set of challenges emanating from the complexity of trials, associated with unique mechanism of action of drugs, their efficacy and safety profiles, which has to be dealt with properly. Conclusion: Overall, the pharma domain is at the verge of putting the patient in the spotlight, to achieve a near-real democracy, where the clinical research is the by the patient, for the patient, and, of the patient.

Whom should you start a company with?

Start-ups organizations are increasing rapidly. To overcome “liability of newness,” it is essential for entrepreneurs to compose the right co-founding team. Based on the review of 57 journal articles on start-up co-founding teams and new venture teams, we found that the composition of the team, especially diversity among team members, was frequently studied. However, previous research has only focused on surface-level diversity such as gender, age, functional background, previous experience. Only a very few studies investigated deep-level diversity such as co-founding team members’ value, personality or thinking style. The present study explored what type of diversity is required in start-ups. Since this topic is rarely studied, we first conducted a qualitative study by interviewing with nineteen start-up founders and venture capitalists in Study 1. As a result we found that four individual characteristic factors (extraversion, agreeing to different idea, risk taking, optimism) and four work-related factors (business opinion, speed oriented, big-picture oriented, time perspective) were the key component of deep-level diversity. In Study 2, we conducted a quantitative study to empirically investigate these aspects by a survey to thirty start-up related individuals. The result confirmed that the diversity were required for six aspects deducted from Study 1. For the other factors of optimism and speed orientation, frequency tendency supported Study 1’s result.

Development of the CCRU kit squad: Centralization of biospecimen “kit” management.

295 Background: Personalized medicine has resulted in a rapid increase in biospecimens collection. Each biospecimen collected requires supplies that are provided in the form of “kits”. The number of kit types per protocol ranges anywhere from 2-60, with an average of 30 different kit types per trial. Historically, each trials nurse has managed their own kits resulting in large amounts of nursing time being spent on kit management. Kits took up a large amount of space in clinical areas, including expired kits, and they were being managed in no standardized fashion. Due to rapidly increasing biospecimen volumes, existing methods of kit management were no longer feasible and the CCRU Kit Squad was developed. Methods: Over the course of 12-mos, an extensive assessment of current kit management practices were reviewed with all disease site groups, including workflows and quantities utilized. An e-commerce software platform was selected, and semi-customized to centralize online ordering and receiving of kits, and the creation of a central location was setup for kit storage and daily operations. On-boarding of each group included retrieving existing kits from each nurse, uploading kits to the software, training each nurse to use the software, setting up accounts with each respective vendor for deliveries and re-supply, and disposing of expired kits. Results: Disease site groups were transitioned to the CCRU Kit Squad stepwise from Oct 2016 to Dec 2017 (15-mos), which included 80 nurses, 16 disease site groups, and over 400 clinical trials. By the end of 2017, the average number of kits ordered per day, and per month were 33 and 1003, respectively. Conclusions: The CCRU Kit Squad developed a centralized online service for kit management, thereby reducing administrative burden on clinical trial nurses. It has streamlined the management of biospecimen kits, eliminated wasted space in clinical areas, and facilitated the selection of the right kit for the right test at the right time.

Reducing burdens of site feasibility assessments for conducting clinical trials.

300 Background: Current methods to assess site feasibility for industry-funded clinical trials are onerous and delay patient access to novel treatment options and high-quality clinical trials. Industry sponsors and contract research organizations (CROs) often probe for unnecessary and/or duplicative information. These burdens prolong trial start-up times and are a barrier to site participation in oncology trials. The American Society of Clinical Oncology (ASCO) Research Community Forum convened a task force to identify ways to improve the site feasibility assessment process. Methods: Data were collected in 3 steps: 1) survey to assess site burdens, 2) collation of sample feasibility questionnaires (FQs), and 3) stakeholder meeting to discuss potential solutions. The task force then developed recommendations for process improvements and obtained stakeholder feedback through a survey. Results: 113 oncology practices (66 community, 47 academic) reported completing a median 5 FQs and 2 pre-study site visits (PSSVs) per month. FQs took a median 2 hours to complete whereas PSSVs took a median 4 hours to complete. Most considered FQ (81%) and PSSV (91%) content redundant to information previously provided, and FQs similar between different sponsors (86%). The median time from first contact to first patient enrolled was 6 months. The 40 respondents to the stakeholder survey represented 19 academic- and 9 community-based sites, 8 industry sponsors, and 4 CROs. Most preferred a model with a short FQ plus a PSSV when there was not a prior relationship. If there was a prior relationship, either a PSSV or teleconference was preferred. All stakeholders identified time savings, expedited start-up, fewer staff resources, and cost savings as the greatest benefits. The greatest barriers to adoption were buy-in from sponsors and CROs, and insufficient information about site capabilities. Conclusions: Site feasibility assessments for industry-sponsored trials are important to ensure patient safety and access to high quality clinical trials. However, current methods are inefficient and time and resource intensive. This initiative provided insights about challenges for sites and the viability of a fundamental change to site feasibility assessments. ASCO recommendations are forthcoming on improving processes, standardizing and minimizing questions, and using portals that are effective across all trials and clinical research scenarios.

Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015

Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibility criteria for commercial investigational new drug clinical trial applications submitted to the US Food and Drug Administration Office of Hematology and Oncology Products in 2015. Our findings suggest that eligibility criteria for current cancer clinical trials tend to narrowly define the study population and limit the study to lower-risk patients, which may not be reflective of the greater patient population outside of the study. We discuss potential areas for expanding eligibility criteria to include more patients in clinical trials and design options for clinical trials incorporating expanded eligibility criteria. The broadening of clinical trial eligibility criteria can be considered to better reflect the real-world patient population, improve clinical trial participation, and increase patient access to new investigational treatments.

Partnerships and Collaborations: The Right Alliances for Clinical Trials in Africa

Africa attracts < 1% of all trials conducted around the world. The implication is that proof of safety and efficacy in Africans is lacking for a lot of new therapies. The sizeable proportion of approximately 20% of the global population that Africa represents largely does not have empiric data to support use of new therapies in a population with a distinct genetic and racial profile. Beyond the imperative of evidence-based interventions, Africans carry a disproportionately heavy burden of certain diseases, including prostate cancer, sickle cell anemia, and malaria. It therefore provides opportunity for efficient recruitment of participants for trials for such diseases. However, this advantage has not convinced sponsors to carry out clinical trials in Africa. India and China each have roughly the same population size as Africa, but each presents just one regulatory jurisdiction for clinical trials. Africa has 54 countries, and a sponsor would theoretically need to file 54 different applications to cover the entire continent. Collaboration and partnership among all stakeholders in the clinical trial ecosystem will reduce the burden on sponsors and make Africa competitive as a destination for clinical trials. Collaboration among national regulatory agencies will enable Africa to be treated as one regulatory jurisdiction and reduce administrative burden. Sites and researchers can partner to improve quality, attain necessary certifications, and increase overall efficiency. Central to all of these are clinical research organizations that can coordinate and work across borders to make clinical trial projects seamless. Ultimately, patients will benefit as quality of clinical practice improves and access to new therapies is enhanced.

Clinical trial design for progressive MS trials

The design of clinical trials is a key aspect to maximizing the possibility to detect a treatment effect. This fact is particularly challenging in progressive multiple sclerosis (PMS) studies due to the uncertainty about the right target and/or outcome in phase-2 studies. The aim of this review is to evaluate the current challenges facing the design of clinical trials for PMS. The selection of patients, the instrumental and clinical outcomes that can be used in PMS trials, and issues in their design will be covered in this report.

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Mastering the Clinical Trial Feasibility Process

Clinical trial feasibility comes down to a simple question: if a sponsor runs a clinical trial at a research site, will that trial succeed? 

However, answering that simple question is a complicated process. Sponsors have to determine which research sites have the participants, staff, expertise, and technology to successfully conduct their studies, and sites have to decide which clinical trials they are willing to tackle with the resources they have. 

Historically, sponsors and CROs have struggled to determine site feasibility. 70% of clinical trials experience start-up delays , 80% don’t complete the enrollment phase on time, and 45% miss their projected end dates. 

If research sites want to be chosen for trials, they need to understand what qualities sponsors are looking for. They also need to evaluate their resources and determine which trials are a good match for their site. Here are a few tips to help your team conquer the clinical trial feasibility process.

What do sponsors mean when they talk about clinical trial feasibility?

To determine clinical trial feasibility, sponsors look at sites’ patient populations , resources, data collection procedures, communication skills, and experience. 

But even the best research sites can’t excel at all of these areas equally. Research sites often run dozens of clinical trials while caring for patients who aren’t enrolled in studies. This means that sites need to know which areas they should concentrate on to improve their clinical trial feasibility. 

Researchers from Copenhagen University Hospital surveyed multiple sponsors and CROs to determine which traits they valued most when looking at clinical trial feasibility. 84% of sponsors and CROs responded that patient recruitment was their number one priority when choosing research sites. 

Sponsors and CROs also said that a strong pool of eligible patients was more important than the research site’s level of experience. 75% of sponsors said that they would work with an inexperienced trial site if that site could offer a large patient population. 88% of sponsors also said that they would rather reach their enrollment goals 10% faster than cut their costs by 20%. 

This study mainly focused on sponsors in Nordic countries, but given how often clinical trials struggle with patient recruitment , it’s safe to say finding patients is a priority around the world. Even if research sites don’t have world-famous physicians or cutting-edge equipment, they may still be selected for a clinical trial if they have a large, diverse patient population.

What do sponsors value most?

Before sponsors determine the feasibility of a clinical trial site, they must determine which features are most important for the clinical trial. If the disease being treated is rare or a trial uses precision medicine , the research site’s patient population will be most important. 

For trials that involve common medical conditions, sponsors may want to focus more on what technology a research site has or how experienced their staff is. Only sponsors and CROs can determine which factors to prioritize. But to increase patient recruitment, retention, and diversity , they should be guided by the study’s needs, not just by how familiar they are with a site. 

Sponsors and CROs can also save time and money by evaluating clinical trial feasibility using technology. For example, sponsors and CROs could look up a site’s information in the Shared Investigator Platform to see if a site has essential capabilities. Then they can send more detailed questionnaires exclusively to sites that meet their basic criteria. 

Although in-person site visits are a possibility again, sponsors may also be able to use remote site evaluations in the early stages of the feasibility process. For example, research staff could fill out a walkthrough exercise about their departments and equipment and share their results with the sponsor through an online portal. 

Doing this process online instead of in person saves sponsors time and money and ensures sites don’t have to rearrange their schedules to show a monitor around.

How can sites evaluate their clinical trial feasibility?

Guides to clinical trial feasibility often emphasize how sponsors decide if a site is feasible. While that decision is important, sites also have to decide whether they have the time and resources to take on a particular study. 

For example, The Nationwide Children’s Hospital conducts an internal feasibility evaluation for every research study. They examine whether they have the correct number of staff and a strong patient pool, as well as whether the study could benefit participants. They also discuss whether there are competing studies that would draw on the same patients. 

Dr. Viraj Rajadhyaksha, who has evaluated research sites for Pfizer and Astra-Zeneca, recommends that sites look closely at study designs, regulatory and ethical challenges, timelines, and community partners before committing to a study. 

Many academic medical centers have developed their own clinical trial feasibility checklists . If your site doesn’t have one, you may want to work with your team to create one.

Clinical trial feasibility challenges: finding eligible patients

Finding eligible patients is critical to both sponsors and research sites, but it’s not easy. When determining feasibility, research sites often look at the number of patients at their site who have a specific disease. However, when they account for inclusion and exclusion criteria, they often discover that they have fewer patients than they realized. 

Sites can also overestimate how many eligible patients will want to participate, especially if the study requires a large time commitment or involves a placebo. Sites need to send sponsors realistic estimates of their patient population that account for inclusion criteria and patients simply not wanting to participate. 

If sites overestimate their eligible patient population, they will likely underestimate their recruitment timelines, leading to frustration from the sponsor and the trial being delayed. 

Research sites may need to use creative recruitment methods to increase enrollment, including websites, ads, personalized letters, and reaching out to local clinics. Sites should make sure the sponsor can cover those costs before agreeing to a study. 

Technology can also help with the problem of recruitment. For example, an article in Trials suggests that research sites can search electronic health records to get accurate feasibility numbers. If the EHR data is standardized, sites can set filters to automatically see how many patients are eligible for studies. 

For more on how technology can help with recruitment and patient engagement, check out our guide to healthcare software here .

Clinical trial feasibility challenges: staffing

Research sites often underestimate how many hours a clinical trial will require from their staff. Principal investigators need to make sure they have enough time to meet all of a study’s protocol requirements, which may include patient check-ins, monitor visits, and signing off on logs and reports. 

Giving PIs the ability to sign documents remotely will help with these challenges, but can’t eliminate them. 

Sites also need to think about additional services requested by the protocol. For example, if the protocol calls for patients to have surgery and physical therapy, the site will need to look at the physical therapists’ and surgeons’ schedules before determining the clinical trial’s feasibility.

Working with monitors can also require a great deal of time from clinical research assistants or clinical research coordinators. In-person visits require CRAs or CRCs to show monitors around and guide them to where documents are stored. If sponsors opt for remote monitoring but don’t have an integrated software system, CRAs and CRCs may find themselves copying, scanning, faxing, and emailing documents. 

When sites and sponsors use integrated software, can alleviate some of the challenges of remote monitoring. With the right remote monitoring technology , sites can give sponsors access to see their documents as soon as they’re updated. This way, sponsors will always have the newest versions of trial documents, and CRCs or CRAs won’t have to waste time scanning or emailing data.

Clinical trial feasibility challenges: costs and budgeting

Sponsors pay for research sites’ clinical trial expenses, but it’s important to have an accurate projection of what those costs will be. Sites constantly needing more money to complete a trial can be frustrating for both sites and sponsors. 

Here are a few costs that sites and sponsors sometimes underestimate when determining feasibility: 

1. Start-up costs

Start-up costs remain roughly the same whether the study enrolls many patients or just a few. All of the patient screenings, staff evaluations, and equipment inventories to determine feasibility take time. Effective healthcare software can reduce start-up costs , but not eliminate them.

2. Medical procedures

If a trial requires repeated procedures performed by nurses, physicians, specialists, or surgeons, costs will be much higher. Therefore, sites will need to double-check that the sponsor has offered enough funding to pay all of the professionals involved and to cover all procedures. 

4. Adverse event reporting

Sites don’t always account for how much time adverse event reporting requires, especially serious adverse event reporting. Sites should account for these costs when determining whether the sponsor has given them a sufficient budget to make the trial feasible. 

5. Costs for out-of-town participants

Lower-income patients are less likely to participate in clinical trials, possibly because they can’t afford additional costs like transportation. Clinical research sites need to confirm that sponsors will provide funding for gas or public transit, hotels, and meals when patients need them. Sponsors may also need to provide hotel accommodations for parents or children if a patient has to stay overnight.

By planning for costs that often get forgotten, sites can ensure that a clinical trial is feasible for them while sponsors decide whether the site is a good fit. 

Streamlining the Clinical Trial Feasibility Process

The clinical trial feasibility process is time-consuming, expensive, and necessary. But when sponsors narrow down the attributes that are most important to them and trial sites are realistic about which studies they have the resources for, the process becomes far more efficient.  Clinical trials get underway faster, and those trials have a better chance of finding and retaining the patients that they need. 

To learn more about how software can help with the clinical trial feasibility process, check out our complete guide to remote site access and study start-up . 

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Guest Column | February 22, 2024

Site feasibility tips for cell and gene therapy clinical trials.

By Jessica Cordes, senior consultant, Clinical Excellence GmbH

Advanced therapy medicinal products (ATMPs) are therapies for human use that are based on genes, tissues, or cells and offer groundbreaking new opportunities for the treatment of disease and injury. ATMPs can be classified into three main types:

• Gene therapy medicines: These contain genes that lead to a therapeutic, prophylactic, or diagnostic effect. They work by inserting recombinant genes into the body, usually to treat a disease, including genetic disorders, cancer, or long-term diseases.
• Somatic cell therapy medicines: These contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose, or prevent diseases.
• Tissue-engineered medicines: These contain cells or tissues that have been modified so they can be used to repair, regenerate, or replace human tissue.

Across the world, ATMP definitions vary. In the U.S., the FDA defines ATMPs as “a biological product that is gene therapy, somatic cell therapy, or tissue-engineered product.” The EMA defines ATMPs as “medicines for human use that are based on genes, tissues, or cells.” And in Asia Pacific, the definition of ATMPs varies by country.

While the definitions of ATMPs may vary , the underlying principles remain the same, and they all offer new and innovative ways to treat diseases and injuries. However, they require specialized infrastructure, equipment, and staff to conduct their clinical trials, and the success of these clinical trials depends on the careful selection and qualification of investigators and sites to ensure the trial is conducted in compliance with regulatory requirements and that the rights, safety, and well-being of patients are protected.

Site feasibility assessment can be challenging. Failure to select and qualify investigators and sites can lead to delays in timelines, increased costs, and even the failure of the clinical trial. But the task is even more complex for ATMP, or cell and gene therapy, clinical trials. In addition to requiring specialized infrastructure, equipment, and staff, the investigational product(s) must be appropriately prepared, handled, stored, dispensed, and accounted for. Therefore, it’s essential to have a solid understanding of the regulatory obligations for investigators and sites when it comes to choosing each.

Understanding Regulatory Requirements For Investigators And Sites

According to the ICH E6, Good Clinical Practice 1 , the EC Guideline on Good Clinical Practice specific to Advanced Therapy Medicinal Products (C(2019) 7140 final) 2 , and the EMA’s Guideline on quality, non-clinical, and clinical requirements for investigational ATMPs in clinical trials 3 , investigators must fulfill the following requirements:

• The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical trial.
• The investigator should provide adequate medical care to patients during the clinical trial.
• The investigator should ensure that the clinical trial is conducted in compliance with the protocol agreed to with the sponsor and that the trial is conducted in compliance with GCP and the applicable regulatory requirement(s).
• The investigator should protect the rights, safety, and well-being of patients.
• The investigator should ensure the investigational product(s) are used only following the approved protocol.
• The investigator should promptly report to the sponsor any adverse events that occur during the clinical trial.
• The investigator should maintain adequate and accurate source documents and clinical trial records that include all pertinent observations on each patient.

The guidelines also ask the following of sites:

• The site should have adequate facilities, equipment, and staff to conduct the clinical trial properly.
• The site should have access to an adequate number of patients.
• The site should have adequate procedures to ensure that all patients are informed of the clinical trial details and consent to participate in the clinical trial.
• The site should have adequate procedures to ensure that the clinical trial is conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).
• The site should have adequate procedures to ensure that the investigational product(s) are appropriately prepared, handled, stored, dispensed, and accounted for throughout the clinical trial.
• The site should have adequate procedures to ensure that the clinical trial is monitored adequately.
• The site should maintain adequate and accurate source documents and clinical trial records that include all pertinent observations on each of the trial subjects.

Considering The JACIE Accreditation

The Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) is Europe’s only official accreditation body in the field of hematopoietic stem cell transplantation (HSCT) and cellular therapy 4 . JACIE promotes high-quality patient care and medical and laboratory practice through a profession-led, voluntary accreditation scheme. JACIE accreditation can be helpful for the apheresis unit feasibility assessment as it provides a framework for assessing the quality of the infrastructure, equipment, and staff. JACIE accreditation also can help to ensure that the apheresis unit is conducting the clinical trial in compliance with the protocol, GCP, and the applicable regulatory requirement(s). It is not mandatory but is beneficial for sponsors and provides comprehensive documentation for the feasibility study. If an apheresis unit is accredited by JACI, the sponsor can use this assessment and shorten their own site feasibility assessment.

Sponsor Obligations

The sponsor should predefine a site profile and expectations on the investigator's knowledge and experience as well as the site facility and experience. The site profile should include general aspects as per ICH E6, Good Clinical Practice, and also cell and gene therapy-specific requirements. Furthermore, it should also consider the special requirements of the involved apheresis unit.

Having predefined site feasibility criteria, the feasibility study should collect information accordingly to compare the actual investigator and site experience with the selection criteria. Only those investigators and sites fulfilling all mandatory selection criteria should be approved for clinical trial involvement.

Adding ATMP-Specific Site Selection Criteria

In general, the site profile should include all regulatory requirements, thus, all criteria according to ICH E6, good clinical practice ICH E6(R2), for investigators and sites. For cell and gene therapy clinical trials, I recommend including the following additional criteria:

• Operational Experience Of Staff: The investigator and the site should not only be experienced in the disease but also in conducting complex clinical trials with many visits, various assessments per visit, complex procedures, and extended source documentation. For example, ATMP clinical trials can include more than 15 visits per patient. Visits with apheresis procedures typically take more than 6 hours each and increase the administrative burden for the sites in documenting this procedure, including donor information, procedure protocol, and all quality controls and information required to get entered into the patient health record and electronic case report form.
• Experience With Cell And Gene Therapies: The investigator and site should have experience with cell and gene therapies and have an understanding of the unique requirements of them, including product receipt, storage, preparation, handling, administration, accountability, and destruction. For example, the IMP might be cryogenic and shipped with a dry shipper on the day of planned treatment. The site must be prepared with all required IMP documents and must have enough time and space for documentation and IMP handling because this IMP type is delivered directly to the patient’s bed.
• Internal Collaboration Between Hospital Departments: Cell and gene therapy clinical trials are interdisciplinary, so the investigator and site should effectively collaborate with different departments to ensure all required clinical trial data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).
• Specialized Infrastructure And Logistics With Cryogenic Products: The site should have experience with the logistical setup of cryogenic products, which are often used in cell and gene therapies. Here, the apheresis unit is critical for the starting material, and an excellent communication line by phone or email to the investigator and site should be in place. Typically, the sponsor is in daily contact with the investigator to ensure that all planned activities and the shipment are going smoothly.
• Extended Site Referral Network: The site should have an extended referral network to ensure that an adequate number of patients can be recruited. Here, the sites can work with referral sites that are not experienced in ATMP clinical trials or even clinical trials in general that are seeing the specific patients for the ATMP clinical trials.
• Willingness To Perform Patient Engagement Activities: The investigator should be willing to perform patient engagement activities to ensure that patients are informed of the clinical trial details and consent to participate. This aspect has an increased value for ATMP clinical trials because these are most often conducted in rare diseases with a very high screen failure rate (often more than 75%) due to the genetic stratification.

Site Feasibility Assessment: Two-Part Questionnaire And Visit

For cell and gene therapies, the site feasibility questionnaire is likely more detailed and longer than that of a traditional clinical trial. It will likely cover cryogenic storage and the involvement of many departments at the site as well as the supply of required emergency treatments.

To reduce the site’s burden and complete the feasibility documentation quickly, the questionnaire can be split into two parts: a general part and a shorter trial-specific part. The general part can be collected without a specific trial in question (and thus, without any time pressure), and the trial-specific site feasibility questionnaire can be collected once a trial is planned.

In all aspects, both site feasibility questionnaires together should align with your predetermined site selection criteria, and you should be able to check all requirements in the end. Please define only those site selection criteria that are crucial to approve a site for clinical trial involvement. Later, you will be able to collect all remaining information (like contact details for all involved site personnel) either during the site feasibility visit via your clinical research associate or another questionnaire after you have approved the site. After approval, your site will have a higher motivation to provide you with more details.

At the site feasibility visit, you can check all general aspects of the site (i.e., facility, storage, documentation, personnel, etc.), which are documented by your clinical research associate. Thereby, you can decrease the site’s documentation burden. You also have the chance to assess a potential split into a general site feasibility visit and a clinical trial-specific visit. This will shorten all future feasibility visits for a specific site and, thus, further decrease the site’s burden to invest time in providing redundant information, meeting the monitor, and showing the facility.

• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH E6(R2) Guideline for Good Clinical Practice
• EC Guideline on Good Clinical Practice specific to Advanced Therapy Medicinal Products (C(2019) 7140 final)
• European Medicines Agency. Guideline on quality, non-clinical, and clinical requirements for investigational advanced therapy medicinal products in clinical trials  https://www.ema.europa.eu/en/guideline-quality-non-clinical-and-clinical-requirements-investigational-advanced-therapy-medicinal-products-clinical trials-scientific-guideline
• Foundation for the Accreditation of Cellular Therapy. FACT accreditation. https://www.ebmt.org/jacie-accreditation

About The Author:

Jessica Cordes started her clinical operations career in 2009, working at various companies including Big Pharma and several small to midsize biotech companies. She gained extensive experience on different levels from country study management, global study management, and since 2018, leadership in clinical operations. During her time at Medigene and Immatics, she structured the clinical operations department, built cohesive global teams, and implemented GCP and ATMP compliant processes. For more than 12 years, she has been working in oncology clinical trials (including hemato-oncology as well as solid tumors) and with ATMPs since 2018. Since 2023, she has been working as an independent consultant and trainer , supporting small companies in building their clinical operations group and setting up their clinical trials for success. She also issues a clinical research bi-weekly newsletter and hosts a quarterly discussion .

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Fixing Feasibility: Collaborative Approaches for Redefining and Improving Site Selection

Blog March 21, 2024

The process of assessing clinical trial feasibility is in urgent need of improvement. Aimed at predicting whether a trial at a particular site will succeed, feasibility involves determining whether the site has the necessary patients, staff, technology, and other resources. In turn, site staff must decide whether the site should accept the study based on available resources.{1} The challenges of feasibility assessment are underscored by the fact that around 70% of trials have start-up delays, 80% fail to achieve on-time enrollment, and 45% miss completion targets.{2} With surging trial volumes and continuing staffing challenges, increasing frustrations are shared by sponsors, contract research organizations (CROs), and sites. Collaborative approaches are needed to improve this process.

Nancy Sacco: Feasibility remains a resource and time burden for sites

“Working on the sponsor side earlier in my career opened my eyes to the realities of sponsor expectations during the site selection process,” states Nancy Sacco, PhD, Vice President and Head of Clinical and Site Development Operations at SiteBridge Research Inc. “Now, viewing things at site level, I see the challenges faced when feasibility questionnaires and other materials come their way. Sponsors and CROs each require different documentation, which may be designed for feasibility for a specific study, or may be a general request for information about the site. The amount of effort for the site is a significant and unfair burden—feasibility questionnaires can be anywhere from 10 to 40 pages.”

From the site perspective, study-specific questionnaires are appreciated, since these are more likely to result in project wins, explains Sacco. “[Filling out] ‘pie-in-the-sky’ questionnaires about general site capabilities consumes valuable resources with little chance of business gain, and can cause frustration. These present a resource and time burden for site staff with often no response or follow-up from the requestors.”

Sacco adds that “at SiteBridge, a first-line team that oversees feasibility keeps records of all completed forms. This enables us to rapidly access earlier answers given to particular sponsor. We then focus on pulling the required patient profiling data from the electronic medical record. This helps in terms of efficiency, but there is room for improvement. Use of online versions of questionnaires could save time by including prefilled and automated options. At present, we typically receive a pdf attachment, which must be downloaded, converted to enable it to be filled out, then re-saved and e-mailed back.”

There is also a pressing need for sponsors and CROs to collate feasibility information in a format that makes the whole process more straightforward. “In an ideal world, the information sites provide for feasibility should stay in databases for future sponsor reference,” says Sacco. “Sadly, this does not happen, resulting in duplication of effort by sites and sponsors alike.”

Technology-based site feasibility databases do provide some avenues of improvement, yet miss the opportunity to provide new/frontier sites the opportunities to become successful partners in the clinical studies circle, Sacco adds. Such platforms and databases focus on historical data, leaving sites with both interested physicians and patients behind.

“Anecdotally, I’ve heard of sites drawing a line to answer feasibility questionnaires without a positive acknowledgement of the time and effort these take,” notes Sacco. “Sponsors already pay CROs to carry out feasibility services and site set-up. The process of answering questionnaires would be a good model for some ‘trickle down’ to the site work, such as a payment at an hourly rate to compensate for the time taken. At present in numerous clinical trial budgets, this time is not accounted for, yet adds up to a significant amount given the number of feasibility questionnaires that are sent out.”

This professional acknowledgement of how important sites are to clinical studies would go a long way toward keeping physician-researchers and site staff engaged—helping build a relationship from an early point and likely increasing the willingness to work with a given sponsor or CRO in future, concludes Sacco.

Andrea Bastek: Site Enablement League members share experiences and drive change

In one effort to improve feasibility, a working group has been set up by Florence Healthcare’s Site Enablement League, notes Andrea Bastek, PhD, Vice President of Innovation at Florence Healthcare. “With more than 70 member organizations, the league brings together clinical trial leaders from research sites, sponsors, and CROs,” she explains.{3} “It aims to enhance the trial site experience and drive industry-wide change through technology, process improvements, and best practices.”

The working group was inspired by a recent paper by the American Society of Clinical Oncology (ASCO), concluding that feasibility assessments are “costly, inefficient, unnecessarily burdensome, and resource intensive.” The ASCO paper added that “these methods delay trial start-up, act as a barrier to site participation, and ultimately reduce timely patient access to clinical trials and novel treatments.”{4}

“As we talked through the various issues, it became clear that people on all sides were not aware of other stakeholder challenges with feasibility,” says Bastek. “There was a clear need to align on the major challenges, why they happen, and what downstream impacts they cause. Often, problems are attributed to the site feasibility process, without a full understanding of the downstream impact of decisions.”

Bastek adds, “When sponsors or CROs try to rush site selection—with the goal of reaching first-patient-in as rapidly as possible—they may start the feasibility process before the protocol has been finalized. Site responses may then become invalid if there are protocol changes, causing delays due to renegotiations of contracts or budgets. A different upstream decision—for example, waiting till the protocol is finalized before initiating feasibility—might avoid downstream delays. Site feedback on the protocol could be obtained via a consulting engagement rather than by too-early initiation of the feasibility process.”

The working group’s output was a checklist of factors to consider during feasibility, including how to avoid challenges by having the right information upfront. The group concluded that feasibility approaches do not need to be standardized, but should take account of the impact of upstream decisions on other stakeholders. Broader awareness is needed of the fact that the process could be faster if more time was allowed for the initial steps.

“We have made considerable progress thanks to this open interchange of perspectives not related to specific business decisions,” according to Bastek. “It is rare to have a forum of this kind. Next, we plan to raise awareness of the challenges of feasibility and how they arise. We aim to recruit sites to review, test, and provide feedback on the working group’s findings so that the checklist can be further improved.” More information on how to sign up is available from Bastek at [email protected] .

“In conclusion, the process for assessing feasibility is costly, time-consuming, and necessary,”{5} says Bastek. “With appropriate steps to refine and improve this process, there is potential for stakeholder benefits, including improvements in meeting milestones such as study startup, enrollment, and completion.”

Victor Chen: Steps toward time-saving master agreements

“At Kaiser Permanente, our infrastructure differs from those of academic institutions, so we need to approach feasibility and startup differently,” says Victor Chen, Managing Director of the Clinical Trials Program at Kaiser Permanente. “We have a total of 21 centers in northern California, with research under way at most of them. As a result, we need a very detailed understanding of sponsors’ study requirements to determine whether we can participate in a given study. For example, we need to see the protocol, the lab manual, and the pharmacy manual, and we must understand fine details such as how the study drug is formulated and how it should be stored. We find that some sponsors approach us with fully baked information, while smaller firms often have less experience and learn during our interactions.”

Collaboration and communication are vital to avoid wasted time on either side, according to Chen. “Larger sponsors may have multiple therapeutic divisions that do not necessarily share information about sites,” he notes. “Development of a standard set of feasibility criteria would be a great help in avoiding duplication of effort. An inventory of information relating to these criteria could then be made available to sponsors and CROs.”

As a step to improve efficiency, Kaiser is working with certain major sponsors to develop master agreements covering issues such as intellectual property and indemnification. “Once in place, these can be time savers for everyone, helping expedite contract finalization and study startup,” Chen explains. “We already have a master agreement in place with a device company, and this has been a game-changer in minimizing ongoing budget negotiations. Another element that would be helpful is a centralized institutional review board.”

Working with Florence Healthcare’s Site Enablement League has been “eye-opening,” says Chen. “Together, we are helping the clinical trial ecosystem move forward based on a more unified voice for stakeholders and a better understanding of each other’s perspectives,” he adds.

Amy Bland: Multiple technology platforms are cumbersome for sites

“Our clinical research department at Baptist Health Institute is relatively new, having been set up only three years ago, and we have seen many changes during that period,” says Amy Bland, Director of Clinical Research at Baptist Health Institute for Research and Innovation. “Like all study stakeholders, we need to ensure compliance. We also need to understand how best to protect our site’s interests during negotiations with study sponsors.”

Bland agrees that the Site Enablement League set up by Florence Healthcare has been very helpful. “I’ve really appreciated the mentorship of senior staff at well-established sites,” she notes. “This mentorship has provided fresh ways to look at issues such as study startup. For example, we’re faced with the need to log in to multiple systems, each with a different password. This is cumbersome for everyone—most of all, the busy physicians who oversee our research in areas such as advanced heart failure. Single-sign-on would be an excellent step forward. It would also be helpful if we could provide all sponsors with a standard feasibility questionnaire describing our sites’ capabilities and providing our assessment of feasibility rather than completing separate sponsor forms for each potential study.”

Join Andrea, Victor, Nancy, and Amy at ACRP 2024 [May 3–6; Anaheim, Calif.], as they consider how the frustrations shared by sponsors, contract research organizations (CROs), and sites alike underscore the need for innovative approaches to data collection and site selection that will lead to successful trials. View complete schedule .

Her department is involved with trials at multiple hospitals in Arkansas, so it needs to develop separate documentation for each hospital, adds Bland. “This process is currently under way, with the goal of saving time and minimizing bottlenecks in the feasibility process,” she explains.

Bland adds that knowing that other sites are also assertively advocating for their interests has empowered her department at Baptist Health Institute to do the same. “We have also learned more about how to appropriately delegate activities to various site roles, such as regulatory specialists and study coordinators,” she says. “In future, the Site Enablement League checklist will be extremely helpful as our department grows, helping to streamline processes and achieve further efficiencies.”

• https://florencehc.com/blog-post/mastering-the-clinical-trial-feasibility-process/
• https://www.clinicalleader.com/doc/is-your-site-selection-process-optimized-0001
• https://florencehc.com/press-release/florence-healthcare-announces-the-launch-of-the-site-enablement-league-to-accelerate-clinical-trial-innovation-and-enhance-site-experience/
• https://ascopubs.org/doi/10.1200/OP.20.00821

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Modernizing Site Feasibility and Selection

Study startup is a complicated, multi-faceted process – notoriously prone to delays due to the many stakeholders, systems, and decisions involved. One decision that can greatly impact the success and efficiency of your study is determining which sites you will partner with to conduct the study.

Historically, this process has been littered with pain points and inefficiencies for both sponsors, contract research organizations (CROs), and research sites. Overoptimistic investigators, redundant and duplicative site feasibility questionnaires (SFQs), lack of communication across stakeholders, and more leave room for risk of zero or under-accruing trials. By optimizing your approach to site feasibility and selection, you can remove barriers preventing research sites from delivering the best possible experience for trial participants—and the best possible results for your organization.

The Role of Site Feasibility Questionnaires

Currently, site selection is largely informed by feasibility questionnaires, typically in the form of a survey sent to all prospective investigative sites via email with a fillable survey document attachment or hyperlink to a data capture form field. However, without suitable analytical tools, survey responses gathered from sites may fail to provide enough relevant information to make an informed decision on whether the site is truly capable of reliable performance against the trial protocol. After all, simply collecting data isn’t enough. Establishing a method to collect and analyze relevant and actionable data is a must. Advarra API Gold Partner Devana Solutions’ PROPEL software improves workflows around creating and sending questionnaires in addition to automating data collection and reporting.

Many feasibility questionnaires are antiquated and redundant. They often ask the wrong questions and fail to collect the information required to yield the best decisions. A recent survey conducted by Advarra revealed over half of site respondents don’t believe an SFQ accurately represents their sites’ capabilities. A more precise and accurate feasibility process should provide a realistic assessment of current site capabilities – both therapeutic and physical or facilities-related – and be backed up by historic performance data captured during previous clinical trials completed by the site organization. Today, using a digital platform or software is a must in order for site selection and feasibility analysis professionals to quickly distribute feasibility surveys or questionnaires and, similarly, following distribution to the site-based staff to capture, store, analyze, and act upon site responses.

Obviously, some standard qualifying questions and evaluations about site baseline capabilities must always be included as prerequisites, such as a site’s financial viability and available staff and physical resources like the presence of onsite freezers or secure drug storage units and a patient database, but it’s also important to consider many of the following items during site selection and feasibility:

• Past study performance in terms of startup timelines, enrollment, and outcomes
• Current staffing numbers and turnover rate
• Competing studies potentially impacting patient enrollment
• If the indication is relevant to the site’s local population
• If the study protocol and framework suit the site and region

Beyond simple questions, feasibility surveys can also provide guidance to the site, particularly around aspects of patient recruitment potentially helping to qualify the site organization’s level of interest in being selected for an upcoming trial. For example, incorporating questions in the survey about best practices undertaken in the past by successful sites on a similar study, indication, or patient population, may help to improve the accuracy of your feasibility survey responses. If a texting campaign for patient recruitment worked well in a similar location before, it may be worth adding a question asking the site organization to detail its breadth of marketing capabilities.

Building a more focused set of questions tailored to your specific study will provide you with more robust and actionable site responses. Including such questions will give you more specific insights for use during site visits or follow-up conversations with site-based staff. Good or bad, these findings can help you target the sites most likely to succeed on a trial while saving time and money by avoiding those that might not be a good fit. Site responses can also help influence potential protocol adjustments since sites maintain and foster a relationship with their patient population and tend to have a good grasp on if procedures may or may not be well tolerated.

Communication is the Key to Success

Whether a site is accepted or rejected for a study opportunity, it’s important to provide feedback and communicate clearly to site staff so they can accurately respond to feasibility survey questions and address any deficiencies before the next trial opportunity. In Advarra’s recent survey , respondents revealed almost one in five sites never receive feedback, and another 34% of sites state they very rarely receive feedback on why they were or were not selected for a study.

Naturally, such communication should go both ways. By providing the opportunity for site staff to provide comments or more open-ended answers to some questions, you may yield more useful insights about the protocol, the local patient population, past recruitment successes, and more. Even when communicating rejection or non-award to a site, it can still help establish trust by clearly stating why the decision was made and freeing up that site’s resources for other studies.

About Devana Solutions

Devana Solutions is an innovative cloud-based clinical trial software company that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Our platform bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trial systems.

Devana Solutions is an Advarra API Gold Partner that integrates seamlessly with Advarra’s Clinical Conductor CTMS. Learn more about Clinical Conductor CTMS , Devana Solutions , and other Advarra partners .

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A framework for assessing clinical trial site readiness

John b. buse.

1 Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA

Christopher P. Austin

2 Flagship Pioneering, Cambridge, Massachusetts, USA

S. Claiborne Johnston

3 Harbor Health, Austin, TX, USA

Freda Lewis-Hall

4 Retired from Pfizer Inc., USA

Andrew N. March

5 National Academies of Sciences, Engineering, and Medicine, Washington, District of Columbia, USA

Carolyn K. Shore

Pamela tenaerts.

6 Medable, Inc, USA

Joni L. Rutter

7 National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, Maryland, USA

Associated Data

For supplementary material accompanying this paper visit https://doi.org/10.1017/cts.2023.541.

Clinical trial processes are unnecessarily inefficient and costly, slowing the translation of medical discoveries into treatments for people living with disease. To reduce redundancies and inefficiencies, a group of clinical trial experts developed a framework for clinical trial site readiness based on existing trial site qualifications from sponsors. The site readiness practices are encompassed within six domains: research team, infrastructure, study management, data collection and management, quality oversight, and ethics and safety. Implementation of this framework for clinical trial sites would reduce inefficiencies in trial conduct and help prepare new sites to enter the clinical trials enterprise, with the potential to improve the reach of clinical trials to underserved communities. Moreover, the framework holds benefits for trial sponsors, contract research organizations, trade associations, trial participants, and the public. For novice sites considering future trials, we provide a framework for site preparation and the engagement of stakeholders. For experienced sites, the framework can be used to assess current practices and inform and engage sponsors, staff, and participants. Details in the supplementary materials provide easy access to key regulatory documents and resources. Invited perspective articles provide greater depth from a systems, DEIA (diversity, equity, inclusion, and accessibility) and decentralized trials perspective.

Introduction

The COVID-19 pandemic laid bare the inefficiencies and health inequities of the US clinical trials enterprise, which impede delivery of promising new therapies to the public. Despite the unprecedented success of Operation Warp Speed and the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) trials, early in the pandemic, insufficient trial infrastructure and a lack of coordination hampered the ability of the US clinical trials enterprise to adequately respond quickly. Going forward, there is a need to ensure clinical trial site readiness to meet timelines and recruitment goals, and to speed definitive and actionable evidence relevant to clinical care. Despite ongoing efforts [ 1 , 2 ], the clinical trials enterprise has not yet adequately expanded participation beyond academic research centers and professional research sites. This manuscript is meant to facilitate the engagement of new sites, provide a framework for health systems to expand their clinical trials footprint, and serve as a resource for engagement of new staff, sponsors, and participants.

Trial access remains a challenge for frontline clinicians and people living with disease [ 3 ]. One problem is that the process for initiating a clinical trial site involves multiple complex qualifications [ 4 ]. Sponsors tend to use the same sites repeatedly [ 5 ] – a practice that offers operational and strategic advantages at the expense of generalizability and the inclusion of underserved communities. Local, regional, national, and international regulations add additional hurdles when it comes to streamlining, sunsetting, or harmonizing site qualifications across regions and studies.

While compliance with good clinical practice (GCP) helps ensure the ethical and scientific quality of clinical trials, sites are also required to comply with sponsor-specific qualifications as detailed in feasibility questionnaires, which creates inefficiencies for sites, sponsors, researchers, and the public [ 6 ]. In the absence of consistent and transparent application of baseline qualifications for clinical trial site readiness, the process of site initiation remains fragmented and duplicative. Potential trial sites are burdened by having to repeatedly define quality and determine how to best demonstrate site readiness and meet expectations across different sponsors and studies. This creates particular barriers to participation for community-based sites, which may require additional staff support, infrastructure, and processes to directly and effectively engage in the clinical trials enterprise. The proposed framework provides a harmonized template for sponsors and sites to enhance diversity in recruitment through expansion of ready clinical trial sites.

Several organizations, including the Society for Clinical Research Sites’ Site Qualification Training initiative [ 7 ] and the Site Accreditation and Standards Institute [ 8 ], provide guidance and resources for clinical trial sites to improve the quality and efficiency of trials. Though focused on oncology clinical trials, the American Society of Clinical Oncology has also developed a set of exemplary attributes for trial sites [ 9 ].

The establishment and adoption of a core set of site readiness practices that are applicable across trial sites, irrespective of size, geography, or clinical specialty, should help streamline the process of site assessment for organizations, research teams, sponsors, and participants. A core set of site readiness practices clarifies requirements, reduces duplicative efforts, streamlines feasibility assessments and qualification processes, and diversifies the types of sites that may engage in clinical trials and the populations the trials serve.

For the purposes of this article, a clinical trial site is considered a traditional brick and mortar site: it is the physical location(s) of a clinical facility (e.g., academic medical center, clinic, hospital) where a principal investigator (PI), and those working under the PI’s direction, conduct in-person study activities with trial participants. A site/clinical organization (e.g., hospital) can consist of many research sites (e.g., cardiology and oncology divisions), including community-based practices associated with and/or owned by the organization. However, the site would not include locations where participants complete digital assessments (e.g., electronic patient-reported outcomes), or undergo routine clinical assessments that could be included in trial databases (e.g., labs, procedures, or inpatient/outpatient medical encounters), such as local labs or local health care provider facilities. A forthcoming perspective will focus on decentralized trials (Tenaerts P, Hernandez AF, Lipset C. Clinical trial site readiness for decentralized trials – Fitting trials into today’s world. J Clin Transl Sci. , in review).

The site readiness practices laid out in this article are a simplified and refined set based on existing qualifications required by sponsors which, taken together, are intended to reflect the minimum requirements necessary for a traditional site to effectively conduct definitive trials in accordance with GCP and similar site qualification requirements used by sponsors. Additional resources are provided in Supplement A , which provides greater depth and access to specific training materials. These site readiness practices are intended to be acceptable to any sponsor and broadly applicable to sites regardless of the organization or research team. It is important to note that the site readiness practices are intentionally elementary as they do not take into consideration study-specific protocols or sponsor-specific qualifications that may apply to a particular clinical trial. However, they are designed to be flexible and modifiable to accommodate emerging clinical trial models, including master protocols, platform-based trial designs, or decentralized clinical trials. This article was developed by the Clinical Trial Site Standards Harmonization action collaborative, an ad hoc activity associated with the Forum on Drug Discovery, Development, and Translation at the National Academies of Sciences, Engineering, and Medicine. This article does not necessarily represent the views of any one organization, the Forum, or the National Academies and has not been subjected to the review procedures of, nor is it a consensus study report or product of the National Academies.

Fifty documents used for assessing, monitoring, and auditing US-based clinical trial sites were collected by MMS Holdings, a a global clinical research organization, from 14 research sponsors of clinical trials, including eight pharmaceutical companies, three contract research organizations (CROs), two government agencies, and one academic institution. From these documents, 217 trial site qualifications were extracted covering initial site assessment, site monitoring, site audit, and site closeout checklists. An analysis was conducted by MMS Holdings to identify similarities, differences, and gaps across the 217 trial site qualifications and compare to the International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines [ 10 ]. Site qualifications were categorized based on an initial set of seven domains: site management, infrastructure, continuous quality improvement, human research protection, study management, data management, and study team/investigator.

A small group b consisting of clinical trial experts, including representatives from government, academic health and research systems, pharmaceutical companies, and CROs, were asked to review the catalog of 217 clinical trial site qualifications to identify qualifications that would indicate a clinical trial site’s readiness to support a standard clinical trial from start to finish.

A modified Delphi method was used to select the site qualifications that would be necessary to support clinical trial site readiness. To conduct the review, members of the small expert group completed a series of three online questionnaires, each focused on two to three domains. In each questionnaire, participants indicated the degree to which they considered each site qualification to be important for demonstrating a clinical trial site’s basic readiness to conduct a clinical trial from beginning to end on a scale of 1 (not at all important) to 5 (absolutely essential). Participants also identified additional site qualifications that could be included within each domain. Throughout this process, participants were encouraged to consult with colleagues to solicit additional input. Following each questionnaire, the data were compiled and distributed to the small group members for review and consideration. Over 2017 and 2018, clinical trial experts c then participated in discussions to review the results and further refine the set of site qualifications and domains and consider common principles. The site qualifications identified through this process are the basis for the site readiness practices discussed in this article.

The language for these site readiness practices was refined, and a framework developed across six domains: research team, infrastructure, study management, data collection and management, quality oversight, and ethics and safety (Fig.  1 ). Finally, a subset of the working group participants d carried out a final round of review of the site readiness practices, domain definition, terminology, and common principles.

Common principles and domains for site readiness practices for clinical trial site readiness.

Foundational Common Principles

Three principles – a culture of quality, clinical research literacy, and person-centeredness – cut across all of the site readiness practices and are foundational for sites as they ready themselves to conduct clinical trials. In-depth review of these areas is beyond our scope, but brief descriptions of each principle is provided, along with references to recent work that provide additional detail on how they might be applied in practice.

Culture of Quality

A site possesses a culture of quality when it establishes and demonstrates adherence to processes designed for error prevention or “getting it right the first time” and a process of continuous and incremental improvements. A starting point is setting standards of quality and establishing supporting systems and processes to evaluate and manage quality goals. Sites must have the ability to measure any errors that occur, identify root causes, and apply process improvements for continuous improvement [ 11 – 13 ].

Clinical Research Literacy

Clinical research literacy – an understanding and appreciation for the value, importance, and processes of clinical research at all levels of an organization – enables informed engagement among stakeholders (the public, potential site PIs and research team members, and health care system leaders) within the clinical research enterprise. For the public, special attention should be paid to increase the understanding of the concepts and terms such as “clinical research” and “clinical trials” as well as where studies take place, how long it takes to develop and test a new treatment, and safeguards for study participants. For PIs and the research team, focus on recognition of the elements that make up a valid research endeavor, requirements for regulatory-grade trials, and the differences in approach for clinical practice versus clinical trials is required across the trial workforce and the clinical enterprise. Further resources in clinical research literacy are available [ 14 ].

Person-Centeredness

Inherent in conducting ethical trials is respect for the rights and welfare of trial participants. It is imperative that clinical trials address the needs and concerns of the general public and maintain flexibility to ensure the well-being of trial participants. Researchers should regard participants as equal partners in research. Engagement with trial participants, communities, and the stakeholders that represent their interests should start early in the process, before initiating a clinical trial and ideally when determining research questions. Participant, community, and stakeholder engagement must be sustained, continuing through the dissemination of study results and between individual clinical trials. Trials that are person-centered also acknowledge health disparities and consciously promote health equity through recruiting diverse trial participants and staff, who reflect the demographics of the disease burden. Detailed treatment of the topic is beyond the scope of this publication and an evolving area of scholarship [ 15 , 16 ].

Site Readiness Practices for Clinical Trial Sites

The 40 site readiness practices described in this document are organized and consolidated into 6 domains: Research Team, Infrastructure, Study Management, Data Collection & Management, Quality Oversight, and Ethics & Safety. The article proceeds to briefly describe each domain, followed by a listing of the site readiness practices, which are compiled in Supplement B .

The site readiness practices in this article are not new concepts to clinical trial sites, but variability in sites’ adoption of the clinical trial practices as well as potential future advances in clinical trial practices may warrant a renewed examination of the framework. There is a wealth of guidance materials and resources to assist sites in adopting this framework to aide in self-assessment. Supplement A provides clinical trial sites with links to resources to guide the implementation of the site readiness practices from various trusted organizations and agencies. Moreover, Supplement A offers a non-exhaustive list of ways to demonstrate and document compliance with each of the site readiness practices, which sites can subsequently use to demonstrate the quality of their program to study sponsors, regulators, workforce recruits, participants, and the public.

Research Team

A clinical site research team may include a principal/sub-investigator(s), clinical research associates, research nurses, data managers, study coordinators, pharmacists, biostatisticians, quality assurance managers, regulatory affairs managers, and administrative staff among others. Four site readiness practices are included in the research team domain:

• The research team has sufficient and diverse personnel, to support the roles and functions needed to conduct a clinical trial that is designed to provide a clear answer and enroll trial participants who accurately reflect the population for the disease or condition being studied, with particular consideration for underrepresented and underserved groups.
• The PI is qualified through experience, training, and mentorship to lead and conduct clinical trials and is free from regulatory debarment and other disciplinary actions that would prevent them from practicing medicine and conducting clinical research.
• Sub-investigators and other research team members are qualified through experience, training, and mentorship to conduct clinical trials, are well trained in cultural humility and strategies for engaging with underrepresented communities, and are free from disciplinary actions that would prevent them from conducting clinical trials.
• All research team members receive initial and refresher training to perform clinical trial activities per ICH GCP standards, and as appropriate, have received training that is tailored to an individual’s role and specific to the study protocol.

Infrastructure

Clinical trial infrastructure consists of the physical and operational software, systems, policies, and facilities necessary for a PI and research team to conduct research. This includes interoperable information systems, equipment, supply management, human resource management, talent development capability, administrative, financial, and legal functions, and business continuity planning. There are 12 site readiness practices that inform sites of the requisite clinical trial infrastructure.

• Identify all satellite sites, external and community facilities, and contractors utilized to fulfill the requirements of studies.
• Ensure facilities (including satellite sites, external facilities, and contractors) and equipment are adequate to fulfill the requirements of a study.
• Provide reliable physical and operational infrastructure (e.g., electric power, internet access, telephone, email, and communications).
• Along with community affiliates, store documents, materials, product, and equipment in a secure location protected against theft, damage, tampering, or other harms during the duration of a study.
• Retain study records after the conclusion of a study pursuant to national, state, local, and other applicable requirements and study protocol.
• Safeguard staff and participants and secure virtual and physical assets (e.g., facilities, records, specimens) during a disruption of operations (e.g., natural disaster).
• Maintain essential functions after a major disruption of operations (e.g., natural disaster).
• Protect computers, networks, programs, and data from digital disruptions and attacks.
• Maintain interoperable information systems and technology capabilities (e.g. data standards, quality control), adequate to support clinical trial conduct.
• Initiate study (e.g., execute a contract) in a prompt manner.
• Ensure sufficient processes for hiring and supporting diverse staff to fulfill the roles and functions needed to conduct a clinical trial (e.g., principal/sub-investigators, clinical research associates, research nurses, data managers, and study coordinators).
• Identify and manage conflicts of interest, including complete financial disclosures for research team members, pursuant to national, state, local, and other applicable requirements and study protocol.

Study Management

Managing clinical trial protocols requires dedicated personnel, resources, and tools to manage implementation and fulfillment of the study requirements at a site. Study execution should include plans to promote diversity and inclusivity among trial participants, ensure equal access, and establish and sustain trusting relationships with the community. Responsibilities may begin as early as the planning stage before the trial begins, to final participant follow-up and subsequent dissemination of results. Full compliance with the protocol and appropriate levels of oversight and monitoring during the trial ensure that safety and trial integrity are maintained throughout the study, and that there is accurate collection and reporting of data that informs any results. The study management domain comprises nine site readiness practices.

• Research team utilizes standard operating procedures/processes for the conduct of clinical trials pursuant to national, state, local, and other applicable requirements and study protocol.
• PI monitors and can demonstrate oversight for all study-related activities, including those functions delegated to satellite sites and contractors, including recruitment, enrollment, and retention suitable for reflecting the diversity of the populations affected by the disease or intervention of study.
• Research team can execute study initiation, startup, and close-out procedures in a prompt manner.
• Research team has access to and process for recruiting and retaining eligible study participants, which should include a plan for enrolling adequate numbers of participants from populations that are underrepresented and underserved in clinical trials.
• Research team can collect, handle, label, store, and ship digital and biological samples (e.g., cultures, blood, serum, plasma, urine, feces, tissues, and imaging) with appropriate documentation pursuant to national, state, local, and other applicable requirements and study protocol.
• Research team can handle investigational medical products, devices, and other means of intervention safely and securely and can record receipt, expiry, reconstitution, handling, dispensation, transfer, and/or destruction.
• Research team can establish, maintain, and record calibration for study-specific equipment.
• Research team can maintain essential study documentation before, during, and after a trial.
• Responsible party e must report study results to clinicaltrials.gov within the required times before, during, and after the conclusion of a study and has a strategy for dissemination of research findings to stakeholders and participants.

Data Collection and Management

Data collection and management requires dedicated personnel, resources, and tools that ensure data integrity and lead to generation of high-quality, reliable, and statistically sound data (e.g., statistical design, case report form design and annotation, database design, data entry, data validation, discrepancy management, medical coding, data extraction, and database locking). Five site readiness practices provide guidance on data collection and management:

• Research team implements controls (e.g., audits, system validations, audit trails, electronic signatures, and documentation) for software and systems involved in processing study-related data pursuant to national, state, local, and other applicable requirements and study protocol.
• Research team can collect, access, retrieve, and exchange data in a timely, accurate, and complete manner, according to a statistical plan designed to yield definitive responses to study questions.
• Monitors, sponsor personnel, and regulatory authorities have access to source material, electronic data systems, facilities, and source documents.
• Research team can ensure quality control of data and source documentation to ensure the integrity and proper reporting of study data.
• Research team can ensure blinding/masking, while promoting transparency and trust with study participants regarding how their data will be used and who will have access to it.

Quality Oversight

The outcomes of clinical trials depend greatly on the quality of the data generated. A quality management system, dedicated personnel, and quality monitoring tools are needed to create a culture of quality through process controls and continuous improvement practices, ensuring that research activities are conducted in a manner that complies with regulations, institutional policies, and the study protocol. Three site readiness practices pertain directly to quality oversight:

• Research team can ensure and verify that the quality requirements have been fulfilled pursuant to national, state, local, and other applicable requirements and study protocol.
• Research team members are able and empowered to identify, prevent, report, and correct safety and quality issues in a timely fashion.
• Research team can identify and remediate deficiency findings from regulatory inspections and sponsor audits (e.g., warning letters, FDA Form 483, corrective and preventive action).

Ethics and Safety

Research teams must protect the rights and welfare of all participants engaged in studies. Human research protection programs promote compliance with relevant legal requirements and ethical standards at all levels to protect trial participants, investigators, and sponsors. Components typically include education and training; quality assurance and compliance; and research review units, including institutional review boards. The ethics and safety domain is composed of seven site readiness practices.

• Research team can protect the rights and welfare of trial participants pursuant to national, state, local, and other applicable requirements and study protocol.
• Research team can identify, assess, process, and report safety events (e.g., deviations, malfunctions, deficiencies, and adverse events) pursuant to national, state, local, and other applicable requirements and study protocol.
• Research team can execute an informed consent/assent process that is respectful of participants and pursuant to national, state, local, and other applicable requirements and study protocol.
• Research team can maintain confidentiality for study participants, while promoting transparency and trust with participants regarding how their data will be used and who will have access to it.
• Research team has access to and reports to a properly constituted IRB/ethics committee pursuant to national, state, local, and other applicable requirements and study protocol.
• Research team engages with study participants, especially vulnerable populations (e.g., children, refugees, people with an intellectual or developmental disability) and populations that have experienced medical abuse and exploitation (e.g., racial and ethnic minorities), in an ethical and culturally appropriate manner, and addresses institutional racism through intentional recruitment and engagement strategies.
• Research team clearly communicates study risks and benefits to study participants in a manner that is accessible and culturally/linguistically appropriate.

Widespread adoption of the common principles and site readiness practices outlined above could improve the performance and success of clinical trials by streamlining site selection and trial initiation with a common set of expectations for trial sites and sponsors. A shared understanding of the elements for trial site readiness and appropriate documentation offers an opportunity to reduce the duplicative and burdensome site qualifications that delay trials and can provide a foundation for a broader, more efficient, equitable, and quality clinical trials enterprise. A set of metrics should be identified to show progress over time as qualifications are being adopted. An accompanying perspective from the CTSA program provides suggestions of expanding and harmonizing trial site readiness processes relevant to health care systems [ 17 ].

Additionally, establishing site readiness practices across sites would represent a first step toward a more comprehensive system of widely accepted qualifications and credentialing. The site readiness practices laid out in this article should first be tested and validated before establishing common qualifications, which could be supported by standardized review processes to create site credentialing. As described in an earlier discussion paper, a harmonized system for gauging site readiness and quality, accepted by the NIH, industry, and other major sponsors, could reduce administrative burden for sites, trial leaders, and sponsors [ 18 ]. As qualifications setting and credentialing has improved clinical care in specific areas [ 19 ], it can also be used to gain the broad engagement and systematization required to disencumber and improve the international clinical trials enterprise.

Benefits of Clinical Trial Site Readiness

Buy-in for a shared understanding of site readiness is also a first step for lowering the barrier to entry for clinical trial sites that have not typically participated in the clinical trials enterprise, including community-based practices. Incorporating a diversity of trial sites is crucial for recruiting diverse trial participants, and ultimately for the generalizability of trial results and the ability of trials to inform clinical practice.

Both potential and current sites could use the framework to catalog documentation of site readiness, to appeal to trial sponsors. For sites that are considering participation in clinical trials, the site readiness practices offer a framework, preparing sites for the capabilities and capacity required to conduct a trial. Similarly, the framework clarifies the minimum requirements for operating a trial site and simultaneously describe the complexities inherent in clinical trials. Further consideration of DEIA (diversity, equity, inclusion, and accessibility) issues and the need for enhanced site readiness is provided in an accompanying perspective (Carter-Edwards, Hidalgo B, Lewis-Hall F, Nguyen T, Rutter J. Diversity, equity, inclusion, and access are necessary for clinical trial site readiness. J Clin Transl Sci. , in review).

For current sites, the framework can help recruit research team members and engage new collaborators attracted by strong clinical trial programs. The site readiness practices should promote discussions regarding necessary training for research teams, and the role of clinical trial institutions in developing such training. CTSAs are uniquely positioned to lead the development of training and mentorship programs. For example, organizations such as the Society for Clinical Research Sites have established training programs to prepare researchers [ 20 ], and the Clinical Trials Transformation Initiative offers recommendations to guide qualification training [ 21 ]. Additionally, streamlining training requirements can produce research teams that have the expertise to conduct mentoring, while also providing greater opportunities for staff to focus on clinical trial innovations and refinement of the site readiness practices. They also may encourage greater institution-wide attention and investment in issues for which individual disease-specific investigators may have limited influence, such as contracting and IRB turn-around times. Applying the site readiness practices across individual sites of a multisite trial could reduce protocol deviations, which increase with the number of sites in a trial [ 22 ], by improving the standardization of training, infrastructure, and culture at disparate sites.

Trial sponsors, as well as the CROs with which they work, would also benefit from adoption of the site readiness practice framework. Trial sponsors, which typically require compliance with their own qualifications in addition to GCP standards, can use the site readiness practices to compare to their own assessment processes, identifying discordances or specialty requirements, in addition to considering modifying potentially onerous requirements. For example, requirements that site staff are familiar with a sponsor’s publication policy may add little value to the clinical trial. Sponsors that streamline and implement the site readiness practices would have the valuable advantage of more rapid site identification and startup and could build a consistent track record of successful clinical trial programs. The site readiness practices encourage transparency of safety and quality systems and processes, which can promote early dialog between trial site and sponsor regarding necessary safety measures. As trial sites begin to adopt and adapt the site readiness practices, sponsors could access the expanded pool of potential clinical trial sites, including community-based sites, and sites that can accommodate decentralized trials. Moreover, buy-in from trial sites would enable sponsors to build directories of facilities that have adopted the site readiness practices for rapid inclusion in trials.

For trade and membership associations as well as other interest groups, these site readiness practices can facilitate conversations with association members about clinical trial conduct, site qualifications, and their connection to quality and safety. Additionally, as these site readiness practices reflect common elements applicable to all clinical trial sites, they can help promote further consideration for specialized site qualifications. These groups could also use the framework to help develop clinical trial site accreditation processes, in thoughtful coordination with trial sites.

The common principles and site readiness practices elevate person-centeredness in clinical trials and promote responsible and ethical engagement of participants and the general public. The site readiness practices endeavor to embed the tenets of diversity, equity, inclusion, and accessibility into clinical trial sites. These tenets are fundamental to the conduct of clinical trials that generate actionable evidence for use in clinical practice. These site readiness practices also make clinical trial processes and safeguards more transparent to the general public and trial participants. Transparency in these processes can engender greater trust in clinical trials. Similarly, adoption of the site readiness practices provides the public and potential trial participants with greater assurances of quality and safety at the trial site. Trial participants will benefit from a greater understanding of how their personal data is being used in the trial, and from appropriate security measures to protect their data. Ultimately, the site readiness practices aim to reduce the time it takes for drug discoveries to be translated to clinically accepted therapies that people living with disease can access.

Approaches to Adoption and Implementation

As a next step toward broader uptake of these site readiness practices, organizations should implement, evaluate, and refine the framework with different trial sponsors through a continuous quality improvement process. Organizations should conduct quantitative measurements for trial outcomes f (e.g., duration of recruitment process and number of protocol deviations) and qualitative assessment of the research teams’ experience with the site readiness practices (e.g., practicality of documenting compliance and burden on research team) and disseminate results in the medical literature.

Call to Action

The wealth of clinical trial experience during the COVID-19 pandemic has shown us that we can execute high-quality, well-designed, definitive clinical trials; and it also showed us that we still need to improve. The starkness of existing inadequacies in the qualifications designed to produce informative, high-quality trials – or the variable implementation of these qualifications – has been made clear and must be addressed. This framework highlights key domains of expectation for organizations to be ready to conduct clinical trials. Supplement A will allow organizations to assess and evaluate their status, take action for addressing inadequacies, and ensure that they are ready for conducting future clinical trials. Adoption of these readiness metrics will usher better, more impactful, and more equitable clinical trials.

Acknowledgments

The authors would like to thank the members of the working groups that contributed to the selection and refinement of the site readiness practices (see footnotes b–d), as well as to Laura Runnels, who facilitated the refinement process. The authors also extend their gratitude to current and former staff of the National Academies of Sciences, Engineering, and Medicine’s Forum on Drug Discovery, Development, and Translation who have contributed their time and expertise: Anne Claiborne, Elizabeth Colvin, Rebecca English, Rita Guenther, Robin Guyse, and Eeshan Khandekar. The authors also thank the members of the Forum on Drug Discovery, Development, and Translation for their guidance on the development of the action collaborative on Clinical Trial Site Standards Harmonization. JBB’s effort was supported by a grant from the National Institutes of Health’s National Center for Advancing Translational Sciences (UM1TR004406).

a For more information, see https://www.mmsholdings.com/ (accessed July 5, 2022).

b Working group participants included: Arti Bajpai (Compliance and Quality Integration Consulting); Tracy H. Blumenfeld (RapidTrials); Peter G.Cheryl Gandinetti (Center for Drug Evaluation and Research, FDA); Peter G. Goldschmidt, co-lead (Health Improvement Institute); Cheryl Lutz (IQVIA); Douglas Peddicord, co-lead (Association of Clinical Research Organizations); Ana Pujols McKee (The Joint Commission); and Peter Vasilenko (Alion HRPP Accreditation Program). Affiliations reflect those at the time the working group met, over the fall of 2013.

c Clinical trial experts included: Anand Mohanish (Pfizer Inc.); Arti Bajpai (Compliance and Quality Integration Consulting); Beverly Brown (Allergan); Ed Connor (I-ACT for Children & George Washington University School of Medicine); Jacqueline Corrigan-Curay (Center for Drug Evaluation and Research, FDA); Federico A. Feldstein (Johnson & Johnson); Grant D. Huang (Department of Veterans Affairs); Anne Marie Inglis (GSK); S. Claiborne Johnston (The University of Texas at Austin); Nya Karanga (Sanofi US); Edward S. Kim (Levine Cancer Institute, Carolinas Healthcare System); Ellen Leschek (National Institute of Diabetes and Digestive and Kidney Diseases, NIH); Freda Lewis-Hall (Pfizer Inc.); Claudia Scala Moy (National Institute of Neurological Disorders and Stroke, NIH); John Oidtman (EMD Serono Inc.); Gail D. Pearson (National Heart, Lung, and Blood Institute, NIH); Jorge Rodriguez-Larrain (Alexion Pharmaceuticals); Matthew T. Roe (Duke Clinical Research Institute); Archana Sah (Genentech, Inc.); Monica Shah (IQVIA); Gina A. Gorgone Simone (Emmes); Reneé Smith (Sarah Cannon Research Institute); and Pamela Tenaerts (Clinical Trials Transformation Institute). Affiliations reflect those at the time the working group considered the site readiness practices, from November 2017 to March 2018.

d The subset of working group participants included S. Claiborne Johnston (Dell Medical School), Arti Bajpai (Compliance and Quality Integration Consulting), Ed Connor (I-ACT for Children & George Washington University School of Medicine), Grant D. Huang (Department of Veterans Affairs), Joseph Pollarine (Johnson & Johnson), Monica Shah (IQVIA), and Gina A. Gorgone Simone (Emmes). Affiliations reflect those at the time the working group met to refine the site readiness practices, in September 2018.

e For more information on who qualifies as a responsible party, see https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-11 (accessed August 15, 2022).

f The CTTI Quality by Design Metrics Framework discusses nine example metrics that clinical trial sites can measure to evaluate the effects of implementing the site readiness practices from this article. https://ctti-clinicaltrials.org/wp-content/uploads/2021/06/CTTI_QbD_Metrics_Framework.pdf (accessed September 8, 2022).

Supplementary material

JBB has contracted consulting fees and travel support for contracted activities paid to the University of North Carolina by Novo Nordisk; grant support paid to the University of North Carolina by Dexcom, NovaTarg, Novo Nordisk, Sanofi, Tolerion and vTv Therapeutics; payments for consultation from Alkahest, Altimmune, Anji, AstraZeneca, Bayer, Biomea Fusion Inc., Boehringer-Ingelheim, CeQur, Cirius Therapeutics Inc., Dasman Diabetes Center (Kuwait), Eli Lilly, Fortress Biotech, GentiBio, Glycadia, Glyscend, Janssen, MannKind, Mediflix, Medscape, Mellitus Health, Moderna, Pendulum Therapeutics, Praetego, ReachMD, Sanofi, Stability Health, Valo, Zealand Pharma; stock/options in Glyscend, Mellitus Health, Pendulum Therapeutics, PhaseBio, Praetego, and Stability Health.

The views expressed within this article do not necessarily represent the views of the National Academies of Sciences, Engineering, and Medicine, the National Research Council, or any of their constituent units. JBB, CPA, SCJ, FL-H, PT, and JLR are all current or former members of the Forum on Drug Discovery, Development, and Translation, a standing body of the National Academies.