An Overview and Guide to Clinical Trial Endpoint Adjudication

Over the last few years the majority of drugs approved by the FDA have been approved based on results obtained using independent adjudication committees. The data from these committees are often used to determine primary safety and efficacy endpoints and are of paramount importance to drug and device approvability. Yet little regulatory guidance is provided regarding how these committees should be designed and performed.

Besides being a mechanism to remove bias, by using integrated teams of sub-specialty trained clinical experts, independent adjudication committees may also increase the accuracy and precision of any subjective assessment. In addition, a central adjudication can provide a solution to the variability in endpoint definition based on standard of care caused by trials becoming more global and of longer duration.

This webinar will provide an overview of the independent endpoint adjudication process with a focus on understanding what is necessary to operationalize an endpoint committee. During this session you will:

• Learn to determine what data needs independent adjudication and what type of adjudication paradigm fits what type of data
• Be introduced to the limited guidance that exists regarding endpoint adjudication and how to develop the critical regulatory document, the “Endpoint Charter”
• Become familiar with the technological considerations for developing a cost effective and fully digital endpoint adjudication process
• Be provided with a clinical perspective on the differences between clinical assessments made in the practice of medicine versus independent assessments utilizing selective clinical trial data
• Learn how to develop an on-study training and testing program for your adjudicators to maximize accuracy and precision of their assessments
• See case histories utilizing different adjudication paradigms and processes

If you are designing trials with subjective endpoints this webinar may benefit your design. Whether you are from a biotech, pharmaceutical, or medical device company with responsibility or involvement in Clinical Operations, Project Management, Medical Affairs, Pharmacovigilance, Protocol Development, Biostatistics, or Data Management, you will come away with tools that can bring your trials greater accuracy and precision.

Speakers

Richard Walovitch, PhD, President, WorldCare Clinical

Dr. Walovitch joined WCC as Chief Medical Officer in January 2009. Prior to joining WCC, he served as the Senior Vice President of clinical research at Acusphere, Inc., Vice President of Preclinical and Clinical Research at Epix Medical, and held various positions as Research Pharmacologist and Project Clinician in the Imaging Agent Group at the DuPont Merck Pharmaceutical Company. He completed his postdoctoral fellowship at the National Institute on Drug Abuse’s Addiction Research Center in the Neurochemistry section. Dr. Walovitch has a Doctorate in Pharmacology from the University of Illinois Medical Center and a Bachelor’s degree in biology from the University of Illinois. He is the author of more than 100 peer- reviewed publications, mostly in the field of medical imaging.

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Glenn Bubley, MD, Director of Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center

Dr. Bubley’s specialties are hematology, internal medicine, and medical oncology. Dr. Bubley is certified by the American Board of Internal Medicine with a Sub-specialty in Medical Oncology. He is an Associate Professor of Medicine at Harvard Medical School and the author over 100 articles, chapters, and editorials. His areas of expertise include Genitourinary Cancers, DNA damage, Glandular & Hormone Dependent Cancers and Oncology adjudication paradigms. Dr. Bubley has worked with WCC for over 10 years on multiple adjudication programs.

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