Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?
Open accessAbstract
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.
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Pragmatic trials give more information regarding the feasibility of integrating a treatment within existing care because they are provided closer to real-world circumstances.
“pragmatic trials, because they are provided closer to ‘real-world’ circumstances, give us more information regarding the feasibility of integrating said treatment within existing care.”
From Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial (2024) · cites this paper as [20]
The paper (Abstract; page unavailable) says pragmatic trials reflect real-world treatment conditions and may teach us more about how best to deliver treatment. It does not specifically say they establish the feasibility of integrating treatment into existing care, and it presents the informational benefit as a possibility rather than a certainty. (LLM, conf=0.83)
Experimental — accuracy not yet measuredTrials integrated within real-world clinical pathways provide access to a participant sample more realistically representing the target population, thereby enhancing external validity.
“Trials integrated within real-world clinical pathways also provide access to a participant sample more realistically representing the target population, thereby enhancing the external validity of obtained results [20, 21].”
Experts in psychedelic-assisted therapy research have drawn attention to the need for trials that are more pragmatic in nature.
“experts in the field of PAT research have drawn attention to the need for trials that are more pragmatic in nature [20]”
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References 65 · Cited by 51
- Authors
- Carhart-Harris, R. L., Wagner, A. C., Agrawal, M., Kettner, H., Rosenbaum, J. F., Gazzaley, A., Nutt, D. J., & Erritzoe, D.
- Affiliations
- Imperial College London (GB)
- Toronto Metropolitan University (CA)
- Maryland Oncology Hematology (US)
- Massachusetts General Hospital, Harvard Medical School, Boston, USA
- University of California, San Francisco (US)
- Centre for Psychedelic Research, Imperial College London, London, UK
- Corresponding author
- Carhart-Harris, Robin L
- ORCID
- Venue
- Journal of Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2021-04-22
- Volume
- 36
- Issue
- 1
- Pages
- 6-11
- ISSN
- 0269-8811 (ISSN-L)
- 1461-7285
- PMC
- PMC8801625
- OpenAlex
- W3154528253
- Cited by
- 51
- References
- 65
- Citations by year
- 2026: 7 · 2025: 6 · 2024: 11 · 2023: 9 · 2022: 13 · 2021: 5
- FWCI
- 6.47
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Journal of Psychopharmacology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- Funders
- National Institute for Health and Care Research (ACF-2013-21-501, CL-2017-21-004)
- Academy of Medical Sciences (SGL019\1063)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- psychedelic therapy, pragmatic trials, real-world data, digital health, confirmatory trials, treatment safety, cost-effectiveness
- MeSH terms
- Drug Development, Digital Technology, Hallucinogens, Humans, Biomedical Research
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