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  4. Public Workshop: Advancing Psychedelic Clinical Study Design - 01/31/2024
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Workshop | Virtual

Event Title
Public Workshop: Advancing Psychedelic Clinical Study Design
January 31, 2024 - February 1, 2024


Date:
January 31, 2024 - February 1, 2024
Day1:
- ET
Day2:
- ET

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The U.S. Food and Drug Administration (FDA), in partnership with the Reagan-Udall Foundation for the FDA, will hold a two-day virtual public workshop, “Advancing Psychedelic Clinical Study Design.” This meeting will bring together researchers, regulated industry, and other key stakeholders to discuss scientific issues that arise while working with psychedelics in clinical trials and drug development.

In June 2023, FDA issued its first draft psychedelics guidance for industry, Psychedelic Drugs: Considerations for Clinical Investigations, to provide general considerations to sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders). While the guidance highlights some of the challenges in designing clinical trials with psychedelics capable of yielding interpretable results, many questions remain about the most appropriate way to address these challenges. This workshop will explore approaches to address key issues in psychedelic drug development and research.

Meeting Goals

  1. Understanding the experiences of scientists working with psychedelics in FDA-authorized clinical studies and drug development;
  2. Exploring considerations for psychedelic clinical trial designs; and
  3. Exploring perspectives and current research on set and settings in psychedelic clinical trials.
 
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