DIA 2018 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-624-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Robert Nelson

Speaker

Additional Safeguards for Children in Research and Protocol Review Under 21 CFR 50.54
Donna L. Snyder, MD

Sponsor Perspective
Jonathan Lu, MD, PhD

Principle Investigator Perspective
Perry Shieh, MD, PhD

Parent Perspective
Brett Bullers

Parent Perspective
Erin Bullers

Patient Perspective
Nicholas Bullers