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Advancing Clinical Research Through Effective Data Delivery

Novel data collection and delivery strategies help usher the clinical research industry into its next era..

The clinical research landscape is rapidly transforming. Instead of viewing patients as subjects, sponsors now use the patients’ input to help reduce the burden they face during trials. This patient-centric approach is necessary to ensure that the clinical trial staff recruit and retain enough participants and it has led the industry to modify all stages of the clinical trial life cycle, from design to analysis. “What we are seeing is a lot more openness to innovations, digitization, remote visits for the patient, and telemedicine, for example,” said Rose Kidd, the president of Global Operations Delivery at ICON, who oversees a variety of areas including site and patient solutions, study start up, clinical data science, biostatistics, medical writing, and pharmacovigilance. “It is becoming a lot more decentralized in terms of how we collect clinical data, which is really constructive for the industry, and also hugely positive for patients.” 

The Increasing Complexity of Clinical Trials

Accurate data is central to the success of a clinical trial. “Research results are only as reliable as the data on which they are based,” Kidd remarked. “If your data is of high quality, the conclusions of that data are trustworthy.” Sponsors are now collecting more data than ever through their trials. 1 This allows them to observe trends and make well-informed decisions about a drug’s or device’s development. 

However, these changes in data volume complicate how clinicians design and run their clinical trials. They must capture enough data to fully assess the drug or device without severely disrupting a patient’s lifestyle. Additionally, the investigational sites must ensure that they have enough staff to collect the data in the clinic or through home visits and keep up with their country’s clinical trial regulations. They also must develop efficient data collection and delivery strategies to ensure a trial’s success. While poorly collected data can introduce noise, properly collected data allows clinical trial leads to quickly consolidate and analyze this information. 2 And they often require support with this process. 

Innovative Solutions to Improve Data Collection and Delivery 

Fortunately, sponsors can find that support with ICON, the healthcare intelligence and clinical research organization. “We essentially advance clinical research [by] providing outsourced services to the pharmaceutical industry, to the medical device industry, and also to government and public health organizations,” Kidd explained. With expertise in numerous therapeutic areas, such as oncology, cell and gene therapies, cardiovascular, biosimilars, vaccines, and rare diseases to mention just a few, ICON helps the pharmaceutical industry efficiently bring devices and drugs to the patients that need them, while ensuring patient safety and meeting local regulations. 

One of the areas that Kidd’s team is specifically focused on is providing solutions to advance the collection, delivery, and analysis of clinical data.

The platform that ICON provides to support sponsors in this regard not only stores data directly entered into the system by clinicians during their site or home visits, but also serves as an electronic diary for patients to remotely record their symptoms as they happen. This makes it easier for patients to participate in clinical trials while maintaining their jobs and familial responsibilities. Moreover, this solution provides clinical trial staff with insights into their data as they emerge, such as adverse event profiles and the geographical spread of these events. However, this requires that the data is input into the system in the same manner at every participating site. 

To address this problem, ICON’s solutions also include a site-facing web portal that helps to reduce the training burden by standardizing data capture and allowing site teams to learn key information about a drug or device. The portal also offers a visit-by-visit guide to ensure that clinicians are asking the necessary questions for a particular visit and helps them remember how to record the data correctly. “It is training at their fingertips when they need it most,” Kidd said. Solutions like these help sponsors obtain the high-quality clinical data that they need to progress from the trial to the market.

Clinical research is evolving and data strategies that support sites and patients alike must similarly evolve. With the right expertise, experience, and technology solutions, ICON is supporting better decision-making by sponsors.

• Crowley E, et al. Using systematic data categorisation to quantify the types of data collected in clinical trials: The DataCat project . Trials . 2020;21(1):535.
• McGuckin T, et al. Understanding challenges of using routinely collected health data to address clinical care gaps: A case study in Alberta, Canada . BMJ Open Qual . 2022;11(1):e001491.

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Safety of a potential new treatment to manage complications from sickle cell disease

Treatment for lung condition could help patients with sickle cell disease control complications from hypertension and kidney damage.

A drug approved to treat pulmonary arterial hypertension may be effective at managing hypertension and end-organ damage in patients with sickle cell disease, according to a new study published in Lancet Haematology . An early phase randomized clinical trial involving 130 patients with sickle cell disease found that the drug, called riociguat, was found to be safe to use and well tolerated in these patients and significantly improved their blood pressure. Preliminary efficacy data suggested the medication might improve heart function.

An estimated 100,000 Americans have sickle cell disease, and the disease occurs in about 1 out of every 365 Black or African-American births, according to the Centers for Disease Control and Prevention. People with sickle cell disease are at high risk for vascular complications that can lead to pulmonary hypertension, stroke, and kidney failure as well as severe pain when red blood cells block blood flow through tiny blood vessels in the chest, abdomen, and joints. These complications can be worsened by hypertension.

Unfortunately, previous research found that sildenafil, an effective treatment for pulmonary hypertension, caused unacceptable side effects in patients with sickle cell disease. It found that those who took this drug experienced high levels of pain that caused increased admissions to the hospital compared to those who took a placebo treatment.

This new study was designed to test the safety of riociguat and how well it works in preventing or reducing the clinical complications for patients with sickle cell disease.

In the study, patients with sickle cell disease and mild hypertension or protein in their urine (an early sign of kidney disease) were randomly assigned to receive either riociguat or a placebo in a double-blind clinical trial. Both groups received the study drug at a starting dose of 1 milligram, which was gradually increased up to 2.5 milligram, taken three times a day for 12 weeks. The researchers found that among the participants who took riociguat, 22.7 percent experienced at least one serious adverse event related to the treatment. In comparison, in the group that received the placebo, 31.3 percent of participants had at least one serious adverse event during the study.

The differences were not statistically significant. There were no differences between the two groups in the rates of pain severity, pain interference in their daily lives, and in vascular events related to their sickle cell disease. When it comes to the effectiveness of the drug treatment, participants who took riociguat had their blood pressure drop by 8.20 mmHg, while those who took a placebo only saw a decrease of about 1.24 mmHg. The result was highly statistically significant, meaning riociguat was much more effective at lowering blood pressure compared to the placebo, with a difference of approximately 6.96 mmHg. In summary, riociguat was found to be safe and led to a significant improvement of blood pressure over the duration of the study.

"Our results are encouraging and open the door to larger clinical trials involving this class of drugs in patients with sickle cell disease who have pulmonary hypertension or kidney disease. Having a drug that's easy to tolerate can help them better manage their blood pressure and help prevent serious complications down the road," said study leader Mark T. Gladwin, MD, who is the John Z. and Akiko K. Bowers Distinguished Professor and Dean of UMSOM, and Vice President for Medical Affairs at University of Maryland, Baltimore.

Bayer Pharmaceuticals, manufacturer of riociguat, provided funding (as well as the drug and placebo) for the study.

The study was led by the clinical and data coordinating centers at the University of Pittsburgh. Study co-authors included faculty from the University of Illinois at Chicago, Albert Einstein College of Medicine, University of Pittsburgh, Emory University, Duke University, Johns Hopkins School of Medicine, and other institutions.

• Sickle Cell Anemia
• Hypertension
• Heart Disease
• Pharmacology
• Diseases and Conditions
• Blood Clots
• Sickle-cell disease
• Pharmaceutical company
• Clinical trial
• Stem cell treatments
• Drug discovery
• Deep brain stimulation

Story Source:

Materials provided by University of Maryland School of Medicine . Original written by Deborah Kotz. Note: Content may be edited for style and length.

Journal Reference :

• Mark T Gladwin, Victor R Gordeuk, Payal C Desai, Caterina Minniti, Enrico M Novelli, Claudia R Morris, Kenneth I Ataga, Laura De Castro, Susanna A Curtis, Fuad El Rassi, Hubert James Ford, Thomas Harrington, Elizabeth S Klings, Sophie Lanzkron, Darla Liles, Jane Little, Alecia Nero, Wally Smith, James G Taylor, Ayanna Baptiste, Ward Hagar, Julie Kanter, Amy Kinzie, Temeia Martin, Amina Rafique, Marilyn J Telen, Christina M Lalama, Gregory J Kato, Kaleab Z Abebe. Riociguat in patients with sickle cell disease and hypertension or proteinuria (STERIO-SCD): a randomised, double-blind, placebo controlled, phase 1–2 trial . The Lancet Haematology , 2024; DOI: 10.1016/S2352-3026(24)00045-0

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April 11, 2024

NSF awards $275K grant to Amplified Sciences to develop new platform of ultrasensitive clinical diagnostics

Amplified Sciences, a clinical-stage life sciences diagnostic company, has received a $275,000 Small Business Innovation Research grant from the National Science Foundation. The funding will support critical development of the company’s tests for early, more accurate detection of challenging diseases, starting with pancreatic cancer. (Purdue Research Foundation photo/Vincent Walter)

State has awarded $50K matching grant through the Indiana Economic Development Corp.’s Applied Research Institute

WEST LAFAYETTE, Ind. — The National Science Foundation has awarded a $275,000 Phase 1 Small Business Innovation Research (SBIR) grant to Amplified Sciences . The clinical-stage life sciences diagnostic company is developing tests for early, more accurate detection of challenging diseases, starting with pancreatic cancer.

Amplified Sciences has received a Phase I matching grant of $50,000 from the Indiana Economic Development Corp.’s Applied Research Institute.

CEO Diana Caldwell said the funding will support critical development of Amplified Sciences’ novel ultrasensitive optical reporter platform technology.

“This, our second SBIR award, will enable further development of multiplexing capabilities for pancreatic cancer panels and beyond,” Caldwell said. “We are excited to be awarded this highly competitive NSF SBIR grant. This brings our total of nondilutive funding to over $1 million.”

Amplified Sciences also recently received investments worth $108,000 from the Flywheel Fund . In 2023 the company received a Phase 1 SBIR grant of approximately $400,000 from the National Cancer Institute and a $50,000 match from the state of Indiana to develop pancreatic cancer risk stratification tests. It was named to the Pepperdine University Graziadio Business School’s Most Fundable Companies list in 2021 and to the New York University Stern School of Business’ Endless Frontier Labs life science cohort in 2022.

The Purdue innovations  

Amplified Sciences’ diagnostic tests are based on technology invented by V. Jo Davisson , professor of medicinal chemistry and molecular pharmacology in Purdue University’s College of Pharmacy and a faculty member of the Purdue Institute for Cancer Research and the Purdue Institute for Drug Discovery . Davisson serves as the company’s chief scientific officer. The company licenses Davisson’s intellectual property through the Purdue Innovates Office of Technology Commercialization .

Facts about pancreatic cancer  

In its Cancer Facts & Figures 2023 report , the American Cancer Society estimated that more than 64,000 Americans were expected to be diagnosed with new cases of pancreatic cancer in 2023. It estimated that more than 50,000 would die from the disease in 2023.

Pancreatic cancer signs and symptoms, like jaundice, severe abdominal pain, weight loss and vomiting, don’t appear until advanced stages of the disease. If a diagnosis is made at an advanced stage, treatments including surgery and pharmaceuticals seldom produce a cure. The five-year relative survival rate is 12% for all patients; for those diagnosed with localized cancer, the rate is 44%.  

About Amplified Sciences

Amplified Sciences is a clinical-stage life science diagnostics startup focused on detecting and preempting the risks of debilitating diseases, thus providing health care professionals the ability to treat patients earlier with better outcomes. The company’s ultrasensitive chemistry platform leverages technology licensed from Purdue University, and its headquarters is in West Lafayette, Indiana. Its lead assay has published clinical evidence in pancreatic cancer. To learn more about Amplified Sciences, visit amplifiedsciences.com .  

About Purdue Innovates Office of Technology Commercialization

The Purdue Innovates Office of Technology Commercialization operates one of the most comprehensive technology transfer programs among leading research universities in the U.S. Services provided by this office support the economic development initiatives of Purdue University and benefit the university’s academic activities through commercializing, licensing and protecting Purdue intellectual property. In fiscal year 2023, the office reported 150 deals finalized with 203 technologies signed, 400 disclosures received and 218 issued U.S. patents. The office is managed by the Purdue Research Foundation, which received the 2019 Innovation & Economic Prosperity Universities Award for Place from the Association of Public and Land-grant Universities. In 2020, IPWatchdog Institute ranked Purdue third nationally in startup creation and in the top 20 for patents. The Purdue Research Foundation is a private, nonprofit foundation created to advance the mission of Purdue University. Contact [email protected] for more information.

Writer/Media contact: Steve Martin, [email protected]

Source: Diana Caldwell, [email protected]

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UH cancer scientist’s passion leads to national changes, community award

• April 9, 2024

University of Hawaiʻi Cancer Center ’s Christa Braun-Inglis was awarded the 2024 David King Community Clinical Scientist Award by the Association of Community Cancer Centers ( ACCC ). Braun-Inglis was recognized for her dedication to cancer research and education. Her focus and commitment to assisting advanced practice providers ( APP s) overcome barriers to their participation in clinical trials has led to a change in national policies.

Related UH News story: National Cancer Institute ‘s Director’s Award for UH researcher

Braun-Inglis is an oncology researcher whose research identified several challenges APPs face. She has made notable progress in expanding their role in National Cancer Institute ( NCI ) clinical trials, aiming to enhance their engagement and representation. Her clinical trial research includes increasing diversity, optimizing cancer care delivery, and focusing on specific areas such as breast cancer.

“It is such an honor to receive the ACCC 2024 David King Community Clinical Scientist Award!” said Braun-Inglis, who was also awarded the 2023 for her achievements in expanding the roles of APP s. “ ACCC ‘s dedication to multidisciplinary, team-based care continues to shine by acknowledging the important role advanced practice providers can play in clinical research.”

The ACCC ‘s endorsement of Braun-Inglis’ proposal for an APP and clinical trials survey initiated national policy changes to broaden the scope of APP roles in clinical trials and implement a novel care delivery research concept. This concept integrates APPs across the NCI Community Oncology Research Program.

Braun-Inglis was honored at the 2024 ACCC Awards Ceremony on March 1 in Washington, D.C., during the organization’s 50th Annual Meeting and Cancer Center Business Summit. The award is named in honor of the late Dr. David K. King, a former president of ACCC , for his lifelong dedication to caring for those with cancer and advocacy for access to quality care.

Related Posts:

• National Cancer Institute’s Director’s Award for UH…
• UH researcher is a voice for Hawaiʻi residents in…
• UH researcher named to breast cancer national committee
• previous post: UH Mānoa kumu tops Merrie Monarch again
• next post: 2 UH alums earn $25 K Milken Educator Award

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UT’s Excellence and Impact On Display in Latest Graduate School Rankings

AUSTIN, Texas — The University of Texas at Austin continues to be one of the premier schools for graduate studies, according to U.S. News & World Report’s partial release of its most recent “Best Graduate Schools.” UT made gains in several disciplines, including the College of Education’s jump into the top 10.

U.S. News has delayed release of its engineering, medicine and clinical psychology rankings, areas in which the University has historically achieved No. 1 and top 10 rankings.

Even with the partial release of the graduate rankings, UT maintained its top 10 spot for five colleges and schools: the College of Education (No. 8); the School of Information (No. 5); the Steve Hicks School of Social Work (No. 8); the College of Pharmacy (No. 6); and the Jackson School of Geosciences (No. 7), ranked under Earth Sciences. Three specialties ranked No. 1 in the country: Accounting, Latin American History and Sociology of Population. Overall, the University has 42 graduate schools and specialty programs ranked in the top 10 when combined with previous years.

“These rankings are striking and reflect our ability to continue to attract exceptional faculty and students. Our excellence is evident in our set of more than 40 schools, programs and specialties ranked in the top-10 in this partial release alone, including several that are the best in the country, if not the world,” said President Jay Hartzell. “Our talent is what puts UT at the leading edge of discovery in AI and robotics, life sciences, population research, and many other disciplines that are at the forefront of solving many of the world’s most pressing problems and bettering society.”

Among the highlights in this year’s rankings:

• The College of Education is now ranked in the top 10, moving up eight spots to No. 8.
• The McCombs School of Business moved up four ranks to No. 16 overall.
• The Information Systems MBA program in the McCombs School of Business is ranked No. 4 this year, marking 31 years that it has ranked in the top 5. Accounting has been ranked No. 1 for 18 years.
• The College of Pharmacy moved up one spot to No. 6. Computer Science moved up one rank to No. 7.
• The Nursing master’s program rose six spots to No. 14.

U.S. News & World Report’s graduate rankings, which are published separately from the yearly ranking of undergraduate programs, are considered the gold standard of graduate and professional rankings. They are based on surveys of academic leaders and, for select programs, additional quantitative measures including placement test scores, student/faculty ratios, research expenditures, salary by profession and job placement success.

The publication updates some of its specialty rankings each year and republishes the most recent rankings in other areas. The rankings for engineering, medicine and psychology will be released at a later date, according to U.S. News.

Graduate schools, programs and specialties that U.S. News ranked in the top 25 are listed below.

Business – 16

• Accounting – 1
• Business Analytics – 8
• Entrepreneurship – 10
• Finance – 13
• Information Systems – 4
• Management – 11
• Marketing – 11
• Production/Operations – 15
• Project Management – 4
• Real Estate – 8
• Supply Chain/Logistics – 16
• Executive MBA – 15
• Part-Time MBA – 7

Education – 8

• Counseling – 15
• Curriculum/Instruction – 12
• Education Policy – 9
• Educational Administration/Supervision – 5
• Educational Psychology – 6
• Elementary Teacher Education – 10
• Higher Education Administration – 14
• Secondary Teacher Education – 10
• Special Education – 7

Health Disciplines (other than Nursing)

• Audiology – 12
• Pharmacy (College of Pharmacy) – 6
• Social Work (Steve Hicks School of Social Work) – 8
• Speech-Language Pathology – 14
• Business/Corporate Law – 17
• Constitutional Law – 11
• Contracts/Commercial Law – 15
• Criminal Law – 20
• Intellectual Property Law – 15
• International Law – 25
• Tax Law – 13

Library and Information Studies Schools (School of Information) – 5*

• Archives and Preservation – 4*
• Digital Librarianship – 7*
• Information Systems – 8*
• Master’s – 14

Public Affairs – 13

• Public Policy Analysis – 15

The Sciences

Biological Sciences – 25*

• Ecology/Evolutionary Biology – 8*

Chemistry – 16*

• Analytical – 4*
• Inorganic – 14*
• Organic – 20*
• Physical – 14*

Computer Science – 7

• Artificial Intelligence – 9
• Programming Language – 7
• Systems – 10

Earth Sciences (Jackson School of Geosciences) – 7*

• Geochemistry – 13*
• Geology – 2*
• Geophysics and Seismology – 5*
• Paleontology – 3*

Mathematics – 13*

• Algebra – 19*
• Analysis – 8*
• Applied Math – 7*
• Topology – 8*

Physics – 13*

• Cosmology/Relativity/Gravity – 10*
• Condensed Matter – 22*

Statistics – 27* 

Social Sciences and Humanities

Economics – 22*

English – 17*

• American Literature After 1865 – 18*

History – 11*

• African American History – 10*
• Latin American History – 1*
• Modern U.S. History – 16*

Political Science – 19*

• American Politics – 20*
• Comparative Politics – 18*

Psychology – 23*

• Behavioral Neuroscience – 8*
• Social Psychology – 9*

Sociology – 11*

• Sociology of Population – 1*
• Sex and Gender – 6*
• Social Stratification – 13*

Fine Arts – 23*

• Sculpture – 6*

*Ranking not revised for 2024-25. Based on latest available ranking.

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