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Thursday, June 18 • 5:00pm - 6:00pm
#512 OD: ON DEMAND - Pediatric Clinical Trial Design and Ethical Considerations: Understanding Prospect of Direct Benefit and Risk

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Component Type: Session
Level: Intermediate

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 Objectives

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.


Donna Snyder, MD


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

Nonclinical Models as Proof-of-Concept to Support Pediatric Clinical Trials
Wendy Halpern, DVM, PhD, MS

Assessing Pediatric Dosing and Adequacy of Trial Duration and PDB
Albert John Allen, MD, PhD, MSc

avatar for Donna Snyder

Donna Snyder

Senior Pediatric Ethicist and Team Leader, Office of Pediatric Therapeutics, OC, FDA
Donna L. Snyder, MD. MBE is the Senior Pediatric Ethicist and Team Leader in the Office of Pediatric Therapeutics (OPT) in the Office of the Commissioner (OC) at the US Food and Drug Administration (FDA). She is a standing member of the FDA Pediatric Review Committee (PeRC) and the... Read More →

Albert Allen

Senior Medical Fellow, Pediatric Capabilities, Eli Lilly and Company, United States
Albert J. Allen, M.D., Ph.D. is the senior medical fellow with responsibility for pediatric capabilities at Lilly Research Labs, Eli Lilly & Co., Indianapolis. A child psychiatrist and pharmacologist by training, A.J. joined Lilly in 2000 and spent 11 years in CNS global drug development... Read More →
avatar for Wendy Halpern

Wendy Halpern

Principal Scientist / Pathologist, Genentech, A Member of the Roche Group
Dr Halpern has been a Scientist/Veterinary Pathologist in the Biotechnology industry for the past 20 years. She is currently employed by Genentech, where she supports a number of drug development programs and also contributes to innovative pediatric drug development across the portfolio... Read More →
avatar for Melanie Bhatnagar

Melanie Bhatnagar

Associate Director for Pediatric Education & Outreach, OPT, OC, FDA
Melanie E. Bhatnagar, MD is the Associate Director for Pediatric Education & Outreach within the Office of Pediatric Therapeutics at the US Food and Drug Administration (FDA). She previously served as a Pediatric Ethicist in which her work focused on supporting review divisions throughout... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session