Title & Introduction

  • Paper Title: Real-world evidence of the collective effects of psychedelic therapy: Evaluating from the grassroots
  • Published In: Journal of Psychedelic Studies
  • Publish date: May 27, 2024
  • Authors: Tehseen Noorani, Rachel Jane Liebert
  • Objective: To explore the potential of real-world evidence (RWE) in assessing the collective effects of psychedelic-assisted therapy (PAT) beyond individual-level pharmacovigilance measures.
  • Importance: Traditional clinical trials focus on individual outcomes, but psychedelic therapy is often linked to broader social transformations. This paper presents a framework for evaluating PAT’s systemic and societal impacts using a grassroots, transformative paradigm.

Summary & Takeaways

Key Takeaway: Traditional measures of pharmacovigilance fail to capture the societal and cultural transformations associated with psychedelic therapy. A grassroots evaluation approach, informed by transformative paradigms, can provide richer insights into PAT’s broader impact.

Practical Application:

  • Develop evaluation frameworks that incorporate social justice perspectives.
  • Consider community-based impacts when assessing psychedelic therapy.
  • Use participatory research models to include marginalized perspectives.

Key Background Information

  • Context: Psychedelic-assisted therapy is increasingly legalized and decriminalized, necessitating real-world evaluation beyond randomized controlled trials (RCTs). Calls for RWE highlight the need to assess PAT’s impact on society.
  • Hypothesis: Evaluating PAT through a grassroots, transformative paradigm can better capture its collective effects and potential for social transformation.

Methodology

  • Study Design: Theoretical analysis proposing a new evaluation model for PAT based on grassroots, community-centered approaches.
  • Participants: Not applicable; conceptual study.
  • Intervention/Exposure: Examination of PAT’s societal influence, considering political, social, and cultural contexts.
  • Controls: Comparison to traditional pharmacovigilance models.
  • Duration: Not applicable.

Key Findings

Primary Outcomes:

  • Conventional pharmacovigilance focuses on individual safety, overlooking PAT’s broader social effects.
  • Evaluating PAT as a "complex intervention" within a larger system allows for a better understanding of its transformative potential.
  • A grassroots approach to evaluation should focus on marginalized expertise and social justice implications.

Secondary Outcomes:

  • Proposed a three-part evaluation framework emphasizing:
    • Rhizomatic Accountability: Decentralized, community-led evaluation processes.
    • Dark Reflexivity: Encouraging uncertainty and self-critical awareness in research.
    • More-than-Human Hosting: Incorporating non-human perspectives (e.g., ecological and Indigenous worldviews).

Interpretation & Implications

  • Conclusion: RWE frameworks must expand beyond individual outcomes to include social, cultural, and systemic effects of PAT.
  • Implications: Future research should prioritize participatory methodologies and acknowledge the non-linear, complex nature of PAT’s influence on society.
  • Limitations: The proposed framework requires further empirical validation and may face resistance from established regulatory institutions.

Researchers & Publication

  • Researchers: Tehseen Noorani (University of Auckland), Rachel Jane Liebert (University of East London)
  • Publication Name: Journal of Psychedelic Studies
  • Study URL: https://doi.org/10.1556/2054.2024.00369
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