Advancing Psychedelic Clinical Study Design: Part 1

In June 2023, FDA issued its first psychedelics draft guidance for industry,
Psychedelic Drugs: Considerations for Clinical Investigations, to provide general considerations to sponsors developing psychedelic drugs for treatment of medical conditions. While the guidance highlights some considerations for designing clinical trials with psychedelics to optimize the interpretability of results, many questions remain about the most appropriate way to address these challenges. The FDA Foundation convened “Advancing Psychedelic Clinical Study Design,” a public meeting to discuss the experience of scientists working with psychedelics in FDA-authorized clinical studies and drug development, considerations for psychedelics in clinical trial designs, and perspectives and current research in psychedelic clinical trials. The meeting also provided an overview of Psychedelic Drugs: Considerations for Clinical Investigations, the FDA’s first psychedelics draft guidance for industry.

Chapters:
0:00 Welcome
1:54 Opening Remarks
7:20 Session 1: Overview of FDA's Psychedelics Clinical Investigation Guidance
36:23 Session 2: Psychedelics Study Design, Control Conditions, and Blinding
1:37:04 Session 3: Dosing
2:46:57 Session 4: Durability of Treatment Response
3:42:20 Adjourn