Byiringiro Samuel, Garcia Juliana K, Farrell Nsenga, Ogungbe Bunmi, Barsha Rifath Ara Alam, Miller Hailey N, Whitaker Evans, Wang Paul, Rosa William E, Bierer Barbara E, Himmelfarb Cheryl R, Michos Erin D, De Lombaert Koen, Berdichesky Maya, Busque Stephan, Palaniappan Latha, Lewis Eldrin, Rodriguez Fatima, Valantine Hannah
School of Nursing, Johns Hopkins University, 525 N Wolfe St, Baltimore, MD, 21205, USA.
Elson S Floyd College of Medicine, Washington State University, Spokane, USA.
Trials. 2025 Apr 2;26(1):117. doi: 10.1186/s13063-025-08820-y.
The lack of diversity in clinical studies has significant ethical and health consequences, limiting the development of effective treatments for diverse populations. Homogeneous participation in clinical studies contributes to health disparities, particularly among historically underrepresented groups in the United States (US). Racial, ethnic, and other minoritized populations have long been excluded from clinical research. In response, the US Congress mandated the National Institutes of Health to assess the impacts of insufficient diversity in clinical studies. Despite efforts by the government, non-profit organizations, and industry players to improve diversity in clinical studies, progress has been slow due to fragmented approaches. For instance, the new US administration (2025) has recently released executive orders which threaten to reverse the progress made in inclusive clinical research. The Stanford Think Tank on Diversity and Equity in Clinical Trials, held in September 2023, brought together key partners across multiple sectors and professions to discuss barriers and explore potential solutions to participation in clinical studies. In this commentary, we discuss the importance of collaborative, inclusive strategies in clinical study design to advance equitable health outcomes for all. Further, we discuss potential implications of the government's dismissal of diversity, equity, and inclusion initiatives on diverse research participation.
临床研究缺乏多样性会产生重大的伦理和健康后果，限制了针对不同人群的有效治疗方法的开发。临床研究中参与者同质化会导致健康差距，在美国历史上代表性不足的群体中尤为明显。长期以来，种族、族裔和其他少数群体一直被排除在临床研究之外。作为回应，美国国会责成国立卫生研究院评估临床研究中多样性不足的影响。尽管政府、非营利组织和行业参与者都在努力提高临床研究的多样性，但由于方法零散，进展一直缓慢。例如，美国新政府（2025年）最近发布了行政命令，有可能扭转在包容性临床研究方面取得的进展。2023年9月举行的斯坦福临床试验多样性与公平性智库会议汇聚了多个部门和行业的关键合作伙伴，讨论参与临床研究的障碍并探索潜在解决方案。在这篇评论中，我们讨论了临床研究设计中采用协作性、包容性策略对于为所有人推进公平健康结果的重要性。此外，我们还讨论了政府摒弃多样性、公平性和包容性倡议对不同人群参与研究的潜在影响。
