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A Failing Flaw in Traditional Clinical Trial Design and How RWE Can Help

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60 Minutes

Diversity in clinical trial populations is critical for adequately assessing the safety and efficacy of new therapies in all patient populations. However, a recent study that compared diversity across randomized clinical trials, the SEER national cancer registry database, and real-world evidence studies, showed that age, ethnicity, and gender are most reflective of the general patient population in real-world evidence studies as compared to randomized clinical trials.1

With these new findings, it is clear the use of real-world evidence is key for increasing diversity in the scientific study of treatments. Join industry experts for this important one-hour discussion to learn more and explore:

  • The current barriers to diversity of age, gender, race and ethnicity in clinical trials
  • A deeper dive into the recent study findings comparing RCT, SEER, and RWE
  • What these findings mean for RWE and health equity moving forward

1. "Comparison of Patient Demographics in Oncologic Randomized Controlled Trials (RCTs) with Real-World Data (RWD) and the Surveillance, Epidemiology, and End Results (SEER) U.S. Population Registry"



Bruce A. Feinberg, D.O.

Bruce Feinberg, D.O., is Vice President, Clinical Affairs and Chief Medical Officer for Cardinal Health. He is nationally recognized for his expertise in specialty oncology and the business of specialty healthcare. Dr. Feinberg has been instrumental in the development of clinical pathways that aim to control costs, improve quality, and increase predictability, all of which are key factors in developing a sustainable approach for caring for patients with high-cost diseases. A highly sought-after researcher and speaker on healthcare policy, value-based care and real-world evidence research, Dr. Feinberg has over 200 publications in peer-review; and he is also the author of the bestselling Breast Cancer Answers and its follow-up book, Colon Cancer Answers.


Danielle Gentile, PhD

Danielle Gentile, PhD is a Senior Scientist on the Real-World Evidence and Insights team at Cardinal Health. She investigates the health outcomes of patients treated in real-world settings outside of clinical trials. Before joining Cardinal Health she served as a Senior Health Services Researcher in the Department of Supportive Oncology at Levine Cancer Institute, Atrium Health in Charlotte, NC where she resides. She earned her PhD in Health Promotion, Education, and Behavior from the Arnold School of Public Health at the University of South Carolina.


Scott Swain, PhD, MPH

Dr. Swain is Director of Regulatory Science and Real-World Evidence with Cardinal Health. His primary duties include developing strategies to incorporate alternative study design methods, such as inclusion of real-world evidence, to improve the quality and increase the efficiency of clients' regulatory submissions. Previously, as Lead Epidemiologist in the FDA/CDER Division of Epidemiology, he led the epidemiology team overseeing real-world evidence safety and efficacy issues for oncology, hematology, and medical imaging products. Dr. Swain earned a PhD in Epidemiology, and a Certificate in Pharmacoepidemiology, from Johns Hopkins University and an MPH in Epidemiology, with a concentration infectious disease, from George Washington University.


Parisa Asgarisabet, PhD

Parisa Asgarisabet, PhD is a Lead statistician on the Real-World Evidence and Insights team at Cardinal Health. Her expertise lies in statistical analysis, database management, and clinical and economic outcomes research of real-world data from chart review forms, administrative claim databases, disease registries, and patient-reported data. She has experience across various therapeutic areas such as oncology, hematology, neurology, and end stage kidney disease. Prior to Cardinal Health, Dr. Asgarisabet spent over 5 years leading research and conducting statistical analysis focused on utilizing Medicare claims and The United States Renal Data System data. Dr. Asgarisabet holds a Doctorate in Health Economics and Health Service Research from University of Texas Health Science Center at Houston. 

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60 Minutes