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DIA 2021 Global Annual Meeting


FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies

Session Chair(s)

Elizabeth  Kunkoski, MS

Elizabeth Kunkoski, MS

  • Health Science Policy Analyst, OMP, CDER
  • FDA, United States
This forum will discuss FDA efforts to modernize clinical trials using clinical practice data, decentralized clinical trials and the inclusion of digital health technologies. FDA experts will provide their perspectives regarding 21 CFR 11. Join us for a student-led follow up round table discussion (session #250.1 RT L) on Tuesday, June 29, 3:00PM - 4:00PM EDT.
Learning Objective : Design and conduct clinical trials using clinical practice data; Discuss the latest developments on decentralized clinical trials for their implementation; Identify how to plan for the inclusion of digital health technologies for remote data acquisition in clinical trials; Discuss how to consider the application of 21 CFR 11 in the conduct of modern clinical trials.

Speaker(s)

Leonard  Sacks, MD

Panelist

Leonard Sacks, MD

  • Associate Director for Clinical Methodology, Office of Medical Policy, CDER
  • FDA, United States
Heather  Stone, MPH

Panelist

Heather Stone, MPH

  • Health Science Policy Analyst, Office of Medical Policy, CDER
  • FDA, United States
Isaac R Rodriguez-Chavez, MHS, PhD, MS

Panelist

Isaac R Rodriguez-Chavez, MHS, PhD, MS

  • Senior Vice President, Scientific and Clinical Affairs, Head, Global COE
  • ICON plc, United States