Anne Katrin Schlag
Head of research, Drug Science

Researching Psychedelics: Real word evidence, naturalistic studies and Randomised Controlled Trials.

Psychedelic assisted therapy (PAT) is increasingly regarded as a novel treatment for a broad range of hard to treat mental health conditions, with both efficacy and safety shown in- relatively small- clinical trials the past decade. As in medical research generally, randomised controlled trials (RCTs) are considered the “gold standard” for developing the evidence base on psychedelics. Yet in addition to the standard limitations of RCTs, such as their lack of ecological validity, psychedelic RCTs face further challenges related to blinding and expectancy effects, therapeutic alliance and the importance of set and setting, which may make it difficult to isolate drug effects per se.

This indicates the value of including additional research methodologies to develop the scientific evidence base. We outline a range of approaches which can be pursued, and which may address some of the shortcomings of current RCTs. These include traditional Real World Evidence (RWE) methods, such as large scale registries, as well as naturalistic approaches, such as case studies, population-based epidemiological work, and Bayesian analysis. Further, we highlight the potential of novel data capture approaches which could offer both large scale data sets and longitudinal outcomes in real world participants. We conclude by outlining recommendations for the development of future psychedelic research, which needs to be able to show the degree to which these medicines are beneficial in the real world. This is crucial to determine the way in which psychedelic medicines should best be developed and ultimately administered in clinical settings. (paper under review).

Dr Anne Katrin Schlag is a Chartered Psychologist and Head of Research at Drug Science. She completed her PhD in Psychology at the London School of Economics and Political Science, before working as Lecturer at King’s College London, and she holds Honorary Fellowships at both Imperial College London and King’s College London. Within her role at Drug Science, she leads the research for the Medical Cannabis Working Group, and the Medical Psychedelics Working Group. The Drug Science Medical Psychedelics Working Group is a cross-sector collaboration that includes scientific experts, academics, policymakers, leaders of patient advocacy groups and industry representatives, collectively aiming to create a rational and enlightened approach to psychedelic research and clinical treatment.