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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
Senior 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)
Additional Safeguards for Children in Research and Protocol Review Under 21 CFR 50.54
Donna Snyder, MD
WCG, United States
Executive Physician
Sponsor Perspective
Jonathan Lu, MD, PhD
Sarepta Therapeutics, United States
Medical Director
Principle Investigator Perspective
Perry Shieh, MD, PhD
UCLA Medical Center, United States
Neuromuscular Medicine Specialist
Parent Perspective
Brett Bullers
United States
Parent
Parent Perspective
Erin Bullers
Parent, United States
Parent
Patient Perspective
Nicholas Bullers
United States
Patient
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