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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)
Melanie Bhatnagar, MD
Associate Director for Pediatric Education & Outreach, OPT, OC, FDA, United States
Understanding Prospect of Direct Benefit as Defined in 21 CFR 50, Subpart D, the Additional Safeguards for Children
Wendy Halpern, DVM, PhD, MS
Principal Scientist / Pathologist, Genentech, A Member of the Roche Group, United States
Nonclinical Models as Proof-of-Concept to Support Pediatric Clinical Trials
Albert Allen, MD, PhD, MSc
Consultant, A. J. Allen Pediatric Drug Development Consulting, United States
Assessing Pediatric Dosing and Adequacy of Trial Duration and PDB
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