Pα+: Day 1 Dispatch from ‘Advancing Psychedelic Clinical Study Design’, Hosted by the Reagan-Udall Foundation for the FDA

On January 31st and February 1st, the Reagan-Udall Foundation for the Food and Drug Administration ¹ hosted a virtual event, Advancing Psychedelic Clinical Study Design.

Using the FDA’s draft guidance for industry—Psychedelic Drugs: Considerations for Clinical Investigations—as a jumping-off point, the meeting saw discussion of a variety of topics: from handling issues like blinding and controls in study design right through to psychedelic use in the ‘real world’.

Beyond hearing from subject matter experts such as psychedelic researchers and industry representatives, it was also a rare opportunity to hear from the FDA about what it wants to see in psychedelic studies, and how it might regulate psychedelic therapies if approved. Through talks from FDA’s Tiffany Fachione as well as representation of the agency in discussion sessions, the FDA gave hints at its regulatory authority and remit, trial design expectations, and more.

The below commentary, written by Psychedelic Alpha’s Josh Hardman, is certainly not exhaustive, but rather aims to share a selection of observations from the event. It’s ordered broadly chronologically. You can review a copy of presentation slides from speakers here: Day 1 / Day 2.

This first issue looks at Day 1...