Bridging the gap between RWD and clinical trials 


In this webinar, our panel of experts will explore the critical limitations of clinical trials and discuss how robust methods can bridge the gap between real-world and clinical trial data.

The high cost, lengthy timelines, and limited patient access of randomized controlled trial (RCTs) are hindering the development of life-saving therapies. We will discuss how real-world data (RWD) can complement and supplement RCTs, offering a more efficient and representative approach to drug development. The webinar will showcase our evolution of methodological processes for fit-for-purpose RWD, including the development of real-world endpoints, and how these advancements are being embraced by regulatory agencies.

Of interest to all working in or interested in RWD/RWE, clinical development, clinical trials, clinical trial operations, regulatory affairs.

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Date and time

Tuesday
1
October
16:00 BST
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What you will learn:

  • Review the history of RWD from pharmacovigilance to comparative safety and effectiveness, to efficacy claims
  • Assess the current state of clinical trials and why change in the process is needed now
  • Discuss recent FDA guidelines on RWD and RWE and the regulatory environment we are operating in today
  • Explore various methodologies and walk through our journey to bridge the gap between RWD and clinical trials 
Speakers:

Bruce Feinberg, DO
Chief Medical Officer, Cardinal Health
 
Bruce Feinberg, DO, 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 health care. 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-reviewed journals; and he is also the author of the bestselling Breast Cancer Answers and its follow-up book, Colon Cancer Answers.

Scott Swain, PhD, MPH
Senior Director, Regulatory and Real-World Evidence, Cardinal Health

Dr Swain is Senior Director of Regulatory and Real-world Evidence at 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. 

Tammy Schuler, PhD
Senior Scientist, Real-World Evidence and Insights, Cardinal Health

Tammy Schuler, PhD, is a Senior Scientist, serving as Lead Scientist on HEOR studies in Real-World Evidence and Insights at Cardinal Health. She has over 10 years of clinical research experience at major medical centers and in industry spanning a broad range of cancer diagnoses. She specializes in patient-reported outcomes and electronic medical records research. Her research has historically focused on retrospective and prospective observational studies, quality of life clinical trials to improve outcomes among individuals and families coping with cancer, and health outcomes research. Prior to her role at Cardinal Health, she was a scientist at Fred Hutchinson Cancer Research Center primarily collaborating on studies in HCT for hematologic malignancies. Recent work by Dr Schuler in the areas of psycho-oncology, health outcomes research, and graduate-level clinical psychology training has resulted in multiple publications and conference presentations.

Moderator:

Laura Dormer
Editor, The Evidence Base
Editor in Chief, Journal of Comparative Effectiveness Research
Editorial Director, Becaris Publishing 

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