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Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial
Session Chair(s)
Robert "Skip" Nelson, MD, PHD
Executive Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
This session presents a case study of the review of a pediatric protocol by a federal panel under 21 CFR 50.54 (Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.). The panel review addressed the ethics of the administration of placebo through a central venous access device in pediatric patients. Parent and patient perspectives were instrumental in informing the panel’s decision and will be highlighted by a family presentation at the session.
Learning Objective : Describe the federal regulations and ethical considerations when using a central venous access device to administer a placebo in a pediatric clinical trial; Discuss prospect of direct benefit, component analysis, and research risk analysis; Recognize how patient engagement and burden can impact risk analysis decisions; Discuss a federal ethics panel review of a protocol referred to the FDA.
Speaker(s)
Donna Snyder, MD
Executive Physician, WCG, United States
Jonathan Lu, MD, PHD
Medical Director, Sarepta Therapeutics, United States
Perry Shieh, MD, PHD
Neuromuscular Medicine Specialist, UCLA Medical Center, United States
Brett Bullers
Parent, United States
Erin Bullers
Parent, Parent, United States
Nicholas Bullers
Patient, United States
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