Journal: Clinical pharmacology and therapeutics
The article is a perspective piece discussing persistent inequities in clinical trial participation, especially among groups that bear a high burden of disease but remain underrepresented in research.
Key points:
- Despite longstanding awareness and policy efforts, women, racial and ethnic minorities, and children continue to be under-enrolled in clinical trials relative to disease prevalence.
- This underrepresentation undermines the generalizability of trial results, limits understanding of differential efficacy and toxicity, and can perpetuate disparities in access to novel therapies.
- The piece synthesizes views from a diverse panel—patients, clinicians, researchers, and advocates—featured at the 2025 American Society for Clinical Pharmacology and Therapeutics Patient Forum.
- The authors focus on practical, “actionable” strategies rather than high-level principles, emphasizing:
- Building trust through bidirectional engagement with communities.
- Reducing structural barriers to participation (e.g., transportation, time, childcare, complexity of consent).
- Improving communication about risks, benefits, and relevance of studies in clear, culturally sensitive language.
- Involving patients and advocates earlier in trial design to ensure eligibility criteria, endpoints, and procedures are feasible and meaningful.
- The overarching message is that equitable representation in trials is not only an ethical priority but also essential to fully realize the clinical value and societal impact of emerging therapies.