Reagan-Udall Foundation for the FDA presents: Good Clinical Practice Considerations for Trials with Pragmatic Decentralized Features (Virtual Meeting)
A Virtual Two-Day Meeting
September 12 & 13
7:30 AM - 9:30 AM US Eastern
Join us on September 12 and 13 to explore Good Clinical Practice Considerations for Trials with Pragmatic or Decentralized Features. The U.S. Food and Drug Administration, in collaboration with the Reagan-Udall Foundation for the FDA, will convene international experts in the conduct of clinical trials with pragmatic or decentralized features. Clinical trials with streamlined protocols
that are embedded in existing health care infrastructure (often referred to as pragmatic trials) and trials with decentralized processes have the potential to generate evidence more efficiently while minimizing the burden on participants.
Representatives from the research community will share their experiences conducting clinical trials with pragmatic or decentralized features. The two-day virtual public meeting will include presentations and moderated discussion to provide a better understanding of the opportunities and challenges of conducting trials with these innovative design features. Learnings from the meetings will inform the development of responsive policies and guidelines that encourage innovation, while protecting participants and safeguarding the reliability of trial results.