Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial
Robert Nelson, MD, PhD
Senior Director, Pediatric Drug Development
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. Include how patient engagement and burden can impact risk analysis decisions; Discuss a federal ethics panel review of a protocol referred to the FDA.
Additional Safeguards for Children in Research and Protocol Review Under 21 CFR 50.54
Donna L. Snyder, MD
Pediatric Ethicist and Team Lead, Office of Pediatric Therapeutics, OC
FDA , United States
Sarepta, United States
Principle Investigator Perspective
Perry Shieh, MD, PhD
Neuromuscular Medicine Specialist
UCLA Medical Center, United States