This perspective article (2023) discusses the ethical considerations of providing post-trial access (PTA) in psychedelic clinical trials. It highlights the unique aspects of psychedelic trials, such as the legal status of psychedelics, the researcher-participant relationship, and the extended therapeutic process, as factors supporting the case for introducing PTA. The authors also advocate for a broader focus on post-trial care beyond access and provide an overview of potential provisions for psychedelic clinical trials, emphasizing the development of infrastructure for the post-legalisation psychedelic medicine ecosystem.
Abstract of When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research
“The ethical value—and to some scholars, necessity—of providing trial patients with post-trial access (PTA) to an investigational drug has been subject to significant attention in the field of research ethics. Although no consensus has emerged, it seems clear that, in some trial contexts, various factors make PTA particularly appropriate. We outline the atypical aspects of psychedelic clinical trials that support the case for introducing the provision of PTA within research in this field, including the broader legal status of psychedelics, the nature of the researcher-therapist/participant relationship, and the extended time-frame of the full therapeutic process. As is increasingly understood, the efficacy of psychedelic-assisted psychotherapy is driven as much by extrapharmacological elements and the cultural therapeutic container as by the drug itself. As such, we also advocate for a refocusing of attention from post-trial access to a broader concept encompassing other elements of post-trial care. We provide an overview of some of the potential post-trial care provisions that may be appropriate in psychedelic clinical trials. Although the World Medical Association’s Declaration of Helsinki calls on researchers, sponsors, and governments to make provisions for post-trial access, such provision may feel impracticable or out-of-reach within psychedelic trials that are already constrained by a high resource demand and significant bureaucratic burden. We show how conceiving of post-trial provision as an integral site of the research process, and an appropriate destination for research funding, will serve to develop the infrastructure necessary for the post-legalisation psychedelic medicine ecosystem.”
Authors: Edward Jacobs, Ashleigh Murphy-Beiner, Ian Rouiller, David J. Nutt & Meg J. Spriggs
Summary of When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research
The World Medical Association’s Declaration of Helsinki, a guiding statement of ethical principles for clinicians undertaking medical research, calls on study providers to offer continued access to favorable treatments beyond the time-limited clinical trial. Although laudable in its aims, the matter of post-trial provisions is a significantly contested space. The Declaration is quiet on the matter of how the responsibility should be divided, and relevant national and international frameworks disagree over the strength and nature of the obligations involved.
The extent of post-trial provisions in clinical trials varies depending on contextual factors. In the current article, we discuss broad ethical considerations specific to psychedelic medicines that support the expansion of post-trial provision, and how such an expansion fits within the wider healthcare ecosystem.
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Jacobs, E., Murphy-Beiner, A., Rouiller, I., Nutt, D., & Spriggs, M. J. (2024). When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research. Neuroethics, 17(1), 3.