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• FDA WORKSHOP: 9th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop - 06/25/2024

Workshop | Virtual

Event Title FDA WORKSHOP: 9th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop June 25, 2024

Modernizing tolerability assessment in cancer clinical trials.

Meeting Registration: 

Twitter: #OCEOutcomes24

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) Patient-Focused Drug Development (PFDD) program welcomes you to the Clinical Outcome Assessment in Cancer Clinical Trials (COA-CCT) 9th annual workshop.

Each year, the COA-CCT workshop provides a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. 

Assessing tolerability from the patient perspective is necessary in cancer trials. Given the availability of PRO symptom item libraries and the growing list of oncology therapeutic mechanisms of action, parsimonious selection of relevant side effects is critical. This year, we will discuss methodologies to select patient-reported treatment-related symptoms to rigorously assess within cancer clinical trials. 

Meeting Goals

• Provide contextual background for patient-reported symptom assessment – an overview of existing “core” symptom sets.
• Review how current clinical trials require novel methods to select symptoms, including use of PRO item libraries.
• Emphasize how early phase trials, pediatric trials, and use of novel agents require parsimonious symptom assessment.
• Consider actionable methods to modernize existing PRO item libraries.
• Discuss a framework for selecting treatment related symptoms across many therapeutic contexts. 
• Review analysis and visualization techniques for treatment related symptoms assessed during cancer trials.

Workshop Materials

• Agenda (forthcoming)
• Biographies (forthcoming)

For past COA-CCT workshops, go to the events section FDA OCE Patient-Focused Drug Development Program webpage.

Caitlin Drew, MSN, RN Senior Health Scientist  Oncology Center of Excellence, (OCE) Office of the Commissioner (OC) U.S. Food and Drug Administration 10903 New Hampshire Ave, Silver Spring, MD 20993 Tel: 301.318.8609 [email protected]

Joan Ferlo Todd, RN Senior Health Scientist  Oncology Center of Excellence, (OCE) Office of the Commissioner (OC) U.S. Food and Drug Administration 10903 New Hampshire Ave, Silver Spring, MD 20993 [email protected]

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• Research Roundtable: ClinicalTrials.gov FAQ — Results Reporting (Part 2)

Research Roundtable: ClinicalTrials.gov FAQ — Results Reporting (Part 2)

Published May 13, 2024

Part two in a series of articles highlighting frequently asked questions to comply with results reporting for  ClinicalTrials.gov  includes guidance on the Quality Control review process, protocol and statistical analysis plans, and appendices. (See part one here .)

ClinicalTrials.gov has an extensive FAQ section ranging from general to investigation-specific. Many of these questions frequently arise not only at the University at Buffalo but also at many other institutions that are part of the Clinical Trials Registration and Results Reporting Taskforce . See additional ClinicalTrials.gov FAQs here .  

How long does the Quality Control review process take?

After the Responsible Party releases (submits) information to ClinicalTrials.gov, the information undergoes a manual quality control review to identify possible errors, deficiencies, or inconsistencies that are not detected automatically during data entry. The Responsible Party will be notified of any issues that need correction, usually within a few days after release of the protocol information. Review of records with results is prioritized for the studies that appear to be Applicable Clinical Trials (ACT) or are NIH-funded and can take up to 30 days or longer. The review process for non-ACTs and studies that are not funded by NIH can be lengthier.

Is a protocol and statistical analysis plan (SAP) required to be submitted?

The regulations require a copy of the protocol and SAP (if not included in the protocol) to be submitted as part of clinical trial results information. The Responsible Party may redact names, addresses, and other personally identifiable information, as well as any trade secrets and/or confidential commercial information.

If there is more than one IRB-approved version of a consent form, how many must be posted?

The Revised Common Rule requires that the version of the consent document that is posted must a) be IRB-approved and b) have been used to enroll a participant in the clinical trial. The version of the consent that should be posted is the most recent IRB-approved version that was used to enroll a participant. 

Are appendices required to be included in the uploaded study protocol?

ClinicalTrials.gov considers the protocol appendices that contain a “description of the clinical trial, including objective(s), design, and methods,” and any “relevant scientific background and statistical considerations,” to be part of the full protocol and as such they must be included with the uploaded protocol. 

When posting a protocol with many add-on sub-studies, which version of the protocol should be posted?

Post the version of the protocol that was originally approved and is relevant to the study at hand. If sub-studies answer the same research questions, register under the originally approved protocol. If sub-studies are clearly different from the main study, each sub-study should be registered separately in ClinicalTrials.gov.

How can I get ClinicalTrials.gov help at UB?

For UB assistance with ClinicalTrials.gov registration and reporting requirements, contact the UB ClinicalTrials.gov team ( [email protected] ) or ClinicalTrials.gov Protocol Registration and Results System (PRS) Administrators Lynn Jagodzinski ( [email protected] ), CTSI Clinical Research Regulatory Administrator, and Urmo “Mo” Jaanimägi ( [email protected] ), CTSI Quality Assurance Specialist.

“Research Roundtable” is a section in the University at Buffalo Clinical and Translational Science Institute (CTSI)   Translational Spotlight  newsletter. Add your email to the newsletter mailing list   here .

Do you have questions or comments for the Office of the Provost? Let us know your thoughts and we’ll be happy to get back to you.

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Triomics raises $15M Series A to automate cancer clinical trials matching

For cancer patients, medicines administered in clinical trials can help save or extend lives.

But despite thousands of trials in the United States each year, only 3% to 5% of eligible patients enroll in investigations of new treatments.

Triomics , a generative AI startup, claims it can significantly reduce the time it takes doctors to match patients with trials.  

Doctors’ recommendations are often key to getting patients enrolled. However, busy oncologists and nurses often lack the time to learn about all the clinical trials that may be right for their patients. 

I am not a doctor, so I don’t know about the day-to-day challenges of oncology medical staff. But I unfortunately know from personal experience how hard it is to find clinical trials for cancer patients. When my father was sick, I spent countless hours poring over clinicaltrials.gov, a website and database that lists thousands of ongoing trials. And just in March, I spent half a Saturday trying to find a clinical trial for a friend who has stage IV cancer. Her doctor only offered one trial, so she asked me if there were other options. 

Since most clinical trials have complex criteria, there are often dozens of factors such as stage of cancer, mutations and previous treatments for eligibility. Medical staff often need hours to manually review a patient’s medical record to find a fitting clinical trial. But due to a shortage of oncology professionals, many cancer patients aren’t offered to participate or they miss their eligibility window. 

Triomics was founded by former MIT biotech researcher Sarim Khan and AI scientist at Adobe Hrituraj Singh. The pair, who have been friends since college, decided to build Triomics in 2021 after realizing that advances in generative AI and LLMs could help extract data from electronic health records (EHR)  to help find appropriate clinical trials for cancer patients in minutes instead of hours.

Khan and Singh entered Y Combinator in the winter of 2021 and proceeded to work on an LLM built specifically for cancer centers and oncology departments in hospital systems. 

Three years later, Triomics says six cancer centers and hospitals are actively using or piloting its LLM, and it plans to double that number by the end of the year. And now the company has raised a $15 million Series A from Lightspeed, Nexus Venture Partners, General Catalyst and Y Combinator to help it continue to develop its platform and roll it out to new customers.

While reducing how long it takes for patients to be matched with clinical trials may seem like the most immediately valuable application of Triomics software, Khan says that Triomics is a lot more than a clinical trials company. “Doctors use it for several different use cases that I could just go on and on about,” he said.

After Triomics’ LLM, which the company is calling OncoLLM, “reads” the patient’s medical record, the data could be used to help prepare doctors and other medical staff for patient visits or to help submit cancer data with details of organs affected and stage of progressions to state regulatory agencies. 

Of course, Triomics isn’t alone in tackling this area. Other startups doing AI clinical trial matching include Deep 6 AI, QuantHealth , Trajectory, among others .

But Khan believes that Triomics is one of the few startups processing large swaths of datasets specifically for cancer centers.

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