Enhanced independence: De-biasing processes in psychedelic research and beyond

Randomized controlled trials (RCTs) are the gold standard for showing treatment efficacy, but they alone do not prevent all bias. This paper reviews conflicts of interest and other biases that challenge methodological rigor in psychedelic RCTs, and recommends four actionable mitigation measures: independent data assessment, multisite trials, quantitative bias analysis, and open science practices. These practices are not specific to psychedelic research and could reduce bias across clinical research fields.

Study at a glance

Abstract

Randomized controlled trials (RCTs) are considered the gold standard for demonstrating the efficacy of a treatment or intervention; however, the RCT study design alone is insufficient to prevent all forms of bias. In this paper, we review conflicts of interest and other biases that pose challenges to the methodological rigor of psychedelic RCTs, and explore recommended bias mitigation measures. We focus on biases of special relevance to psychedelic RCTs and methods of mitigating bias that we believe are actionable and urgent practices to implement in psychedelic research: (1) independent data assessment, (2) multisite trials, (3) quantitative bias analysis, and (4) open science practices. Although we advocate for the adoption of these practices in psychedelic research, they are not psychedelic specific. We suggest that the challenges posed by psychedelic research offer an opportunity for researchers to creatively find and implement solutions across the study lifecycle to reduce bias in other fields of clinical research.