Symposium: The Value of Real World Evidence in Psychedelic Research
- 11:00 - 12:30
- Room: Rudolf-Virchow (2nd floor)
Prof Michael Lynskey (PhD). Drug Science
Psychedelic therapy 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 two decades.
As in medical research generally, randomized 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 Real World Evidence (RWE) approaches which can be pursued, and which may address some of the shortcomings of current RCTs. These RWE approaches include large scale observational data registries, which are already successfully used to study the effectiveness of another- previously illicit- medicine in the real world, i.e., medical cannabis. Furthermore, we present self-blinding citizen science as a promising approach to further our understanding of psychedelics medicines.
We conclude by discussing 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.
· Researching Psychedelics: Randomized Controlled Trials and Real World Evidence (AKS)
· Real World Evidence of Psychedelics: (How) Can We Use Observational Data Registries? (ML)
· Self Blinding Citizen Science to Explore Psychedelic Microdosing and More? (BS)