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

  • Post category:Analysis / Pα+

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Using the FDA’s draft guidance for industryPsychedelic Drugs: Considerations for Clinical Investigations—as a jumping-off point, the meeting saw discussion of a variety of topics: from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.

In this article:

  • FDA’s Tiffany Farchione Reviews the Agency’s Draft Guidance
  • Psychedelic Study Design, Control Conditions, and Blinding
    • Contagion Effects: Suresh Muthukumaraswamy
    • Non-Pharmacological Influences on Outcomes: Franz Vollenweider
    • Discussion
  • Dosing
    • Against Psychedelic Exceptionalism in Trials: Robert Barrow, MindMed
    • “This is a drug, and therefore it’s worthwhile studying it as a drug” — Guy Goodwin, Compass Pathways
    • Lingua Franca: Berra Yazar-Klosinski, Lykos Therapeutics
    • Discussion
  • Durability of Treatment Response
    • The Subjective Elephant in the Room: Michael Bogenschutz
    • Learning from Esketamine: Carla Canuso, J&J
    • Discussion

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