This presentation was given by Dr. Leonard Sacks, Associate Director for Clinical Methodology, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, during our June 2020 Clinical Trials Digital Week.
The talk addresses technology enabled clinical trials, the value of this approach, and the considerations involved in ensuring that measurements made by technologies are reliable. Approaches to decentralizing the conduct of clinical trials are discussed, touching on oversight, safety, and inspections.
