Anne Katrin Schlag - Psychedelic Medicine in the real world: challenges and opportunities.

Psychedelic medicine requires a balanced integration of both randomized controlled trials (RCTs) and real-world evidence (RWE) to overcome the limitations of current clinical research frameworks. While RCTs remain the gold standard, their narrow inclusion criteria and lack of ecological validity often fail to capture the complex interplay of set and setting inherent to therapeutic psychedelic use. Incorporating RWE allows researchers to analyze diverse patient outcomes, improve long-term monitoring, and gain insights into indigenous and community-based practices that lie outside the standard clinical model. Recent developments in Canada and Australia highlight the feasibility of implementing responsible access frameworks. These models enable clinicians to provide psychiatric care while systematically collecting longitudinal data. By leveraging these real-world insights, practitioners can better understand treatment effectiveness in diverse patient populations, ultimately bridging the gap between rigorous pharmacological research and safe, accessible clinical practice.