Virtual Public Meeting on Good Clinical Practice: Considerations for Clinical Trials with Decentralized or Pragmatic 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.

You can contribute to the discussion. Share your questions when you register, and as many as possible will be included in the discussion.

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.

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