From Efficacy to Effectiveness: Evaluating Psychedelic Randomized Controlled Trials for Trustworthy Evidence-Based Policy and Practice
Psychedelics challenge gold-standard RCTs—can MDMA and psilocybin fit traditional models of medical evidence?
The recent review of a new drug application for MDMA-assisted therapy for posttraumatic stress disorder by the United States' Food and Drug Administration (FDA) highlighted epistemological and methodological challenges for evidence assessments. Similar challenges will also be faced in reviews of other compounds in early- and late-stage development, like psilocybin for depression. The regulatory demand for two successful phase 3 randomized controlled trials (RCTs) seems problematic, given a current lack of agreement on what constitutes “success”, particularly when psychoactive drug administration is concomitant with (psycho)therapy.
Click here to access the article.