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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