Good Clinical Practice: Considerations for Trials with Pragmatic or Decentralized Features A Virtual Two-Day Meeting September 12 & 13 7:30 AM - 9:30 AM US Eastern

Good Clinical Practice: Considerations for Trials with Pragmatic or Decentralized Features A Virtual Two-Day Meeting September 12 & 13 7:30 AM - 9:30 AM US Eastern https://reaganudall.org/news-and-events/events/good-clinical-practice-considerations-trials-pragmatic-or-decentralized?utm_medium=email&utm_source=govdelivery Two-Day Virtual Public Meeting on Good Clinical Practice: Considerations for Clinical Trials with Decentralized or Pragmatic Features Join us on September 12 and 13, 2023, to explore good clinical practice considerations for clinical trials. 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. Please save the date for this two-day, virtual public meeting: Tuesday, September 12 and Wednesday, September 13, 2023 7:30 a.m. – 9:30 a.m. ET (same time on both dates) Note that times are set to maximize global participation. 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. You can contribute to the discussion. Share your questions when you register, and we’ll include as many as we can in the discussion. To register and submit questions, click here. The meeting agenda is available and will be updated as more information is provided. Full recordings of both sessions will be available after the meeting along with the complete slide deck and transcript.v