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DIA 2018 Global Annual Meeting


Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial

    Session Chair(s)
      Robert  Nelson, MD, PhD

      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.
    Speaker(s)
      Donna L. Snyder, MD

      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
      John  Lu

      Sponsor Perspective

      John Lu

      • Medical Director
      • Sarepta, United States
      Perry  Shieh, MD, PhD

      Principle Investigator Perspective

      Perry Shieh, MD, PhD

      • Neuromuscular Medicine Specialist
      • UCLA Medical Center, United States
      Brett  Bullers

      Parent Perspective

      Brett Bullers

      • Parent
      • United States
      Erin  Bullers

      Parent Perspective

      Erin Bullers

      • Parent
      • United States
      Nicholas  Bullers

      Patient Perspective

      Nicholas Bullers

      • Patient
      • United States