DIA 2020 Global Annual Meeting

This event is now offered in a new entirely virtual format.

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ON DEMAND - Pediatric Clinical Trial Design and Ethical Considerations: Understanding Prospect of Direct Benefit and Risk

Session Chair(s)

Donna Snyder, MD

Executive Physician

WCG, United States

This session will explore the ethical considerations and level of evidence needed to support a prospect of direct benefit for initiating clinical trials in children, particularly for conditions that are primarily pediatric.

Learning Objective : Describe the ethical principles to be considered when designing a pediatric clinical trial; Recognize that a child should have a prospect of directly benefiting from research when certain levels of risk are exceeded; Identify the level of evidence to support the prospect of direct benefit may differ based on the nature and severity of disease and available alternative therapies.

Speaker(s)

Understanding Prospect of Direct Benefit as Defined in 21 CFR 50, Subpart D, the Additional Safeguards for Children

Melanie Bhatnagar, MD

FDA, United States

Associate Director for Pediatric Education & Outreach, OPT, OC

Nonclinical Models as Proof-of-Concept to Support Pediatric Clinical Trials

Wendy Halpern, DVM, PhD, MS

Genentech, A Member of the Roche Group, United States

Principal Scientist / Pathologist

Assessing Pediatric Dosing and Adequacy of Trial Duration and PDB

Albert Allen, MD, PhD, MSc

A. J. Allen Pediatric Drug Development Consulting, United States

Consultant

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