Anne Katrin Schlag - Researching Psychedelics: Real word evidence, naturalistic studies and Rando...

Randomized controlled trials (RCTs) are not the only way to advance the scientific understanding of psychedelic medicines. Real-world evidence (RWE) and naturalistic study methods offer vital, complementary insights by capturing data from diverse populations and settings outside of traditional and often rigid clinical trial structures. Such approaches are essential for acknowledging the complex interplay between substance, set, and setting, which define the psychedelic experience. While RCTs provide crucial foundations, they often suffer from limited ecological validity, small sample sizes, and significant participant expectancy. Integrating data from large-scale patient registries, electronic health records, and naturalistic observations allows for a more holistic assessment of safety, side effects, and long-term outcomes. Systematically gathering this data is essential for navigating the future of medicine, avoiding past mistakes in the research of controlled substances, and improving patient access.