Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?
Robin Carhart-Harris, Anne C Wagner, Manish Agrawal, Hannes Kettner, Jerold F Rosenbaum, Adam Gazzaley, David Nutt, David Erritzøe
J Psychopharmacol April 22, 2021 DOI: 10.1177/02698811211008567 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Theoretical or philosophical paper Peer reviewed |
|---|---|
| Topics | Psychedelic-assisted therapy |
| Keywords | Psychedelic medicine Innovative treatments Psychopharmacology Psychedelic research Real-world evidence Real-world data Pragmatic research Patient experiences Everyday settings Observational studies Rwe Digital health Digital technologies Apps Mhealth Ehealth Digital therapeutics Healthcare integration Advancing treatments Treatment integration Medical innovation Healthcare innovation Healthcare system |
| Citations | 54 |
| Key points | Proposes that supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives, and digital health solutions can better support the discovery of optimal and personalized psychedelic therapy protocols. |
Abstract
Favourable regulatory assessments, liberal policy changes, new research centres and substantial commercial investment signal that psychedelic therapy is making a major comeback. Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice. Here we suggest supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives and digital health solutions to better support the discovery of optimal and personalised treatment protocols and parameters. These recommendations are intended to help support the development of safe, effective and cost-efficient psychedelic therapy, which, given its history, is vulnerable to excesses of hype and regulation.