Aziz Maryam, O'Brien Emily C, Lusk Jay B, Krishnamurthy Sudarshan, Garcha Vani, Brookhart M Alan, Califf Robert M, Green Michael D
medRxiv. 2025 Jul 21:2025.07.21.25331865. doi: 10.1101/2025.07.21.25331865.
A lack of transparent reporting of race and ethnicity in clinical research limits the ability to identify health inequities and evaluate to what extent clinical research includes diverse populations.
To identify study characteristics associated with reporting race and ethnicity of clinical study participants and to document temporal trends in race and ethnicity reporting on clinicaltrials.gov .
Cross-sectional analysis of interventional trials and observational studies from 2009-2024; multivariable logistic regression assessed study-level factors associated with reporting race and ethnicity.
Global registry of clinical studies ( clinicaltrials.gov ).
58,163 studies with posted results and without early termination.
Study characteristics: sponsor trial phase, study type, and country.
Reporting of race, reporting of ethnicity, reporting of both.
Among 58,163 studies (mean enrollment=1,215 participants), 44.8% did not report race or ethnicity to the repository (mean enrollment=1,481 participants). The proportion of studies reporting both race and ethnicity rose from 7.4% in 2013 to 54.6% in 2024. In multivariable models, observational studies had lower odds of reporting race and ethnicity (odds ratio[OR]=0.55, 95% confidence interval[CI]=0.49-0.61) compared with interventional trials. Phase 4 trials were least likely phase to report race and ethnicity (OR=0.32; CI=0.29-0.35), and studies with only National Institute of Health funding were more likely to report race and ethnicity compared to studies with any industry funding or sponsorship (OR=1.70, CI=1.61-1.79). For studies that reported race, White participants comprised ≥50% each year based on study-level percentages; proportions of Asian participants declined, and Black participants fluctuated. 'Not Hispanic or Latino' remained ≥80% of reported ethnicity annually.
Race and ethnicity reporting on clinicaltrials.gov has improved markedly yet remains incomplete, with shortfalls in late-phase and observational studies.
Among clinical studies registered to clinicaltrials.gov , how often are race and ethnicity reported, how has reporting changed across time, and what study characteristics indicate a higher likelihood of reporting? In a cross-sectional analysis of 58,163 studies with posted results from 2009-2024 to clinicaltrials.gov , most studies did not report race and ethnicity, though rates rose from 7% to 55%. Reporting was less common in observational and late-stage clinical trials, and more common among NIH funded studies. Despite recent gains, incomplete reporting limits generalizable assessment of clinical study participant diversity and warrants stronger oversight.
临床研究中缺乏关于种族和族裔的透明报告，限制了识别健康不平等现象以及评估临床研究纳入不同人群程度的能力。
确定与报告临床研究参与者种族和族裔相关的研究特征，并记录在clinicaltrials.gov上报告种族和族裔的时间趋势。
对2009年至2024年的干预性试验和观察性研究进行横断面分析；多变量逻辑回归评估与报告种族和族裔相关的研究层面因素。
全球临床研究注册库（clinicaltrials.gov）。
58163项已公布结果且未提前终止的研究。
研究特征：资助者、试验阶段、研究类型和国家。
种族报告、族裔报告、两者均报告。
在58163项研究（平均入组人数 = 1215名参与者）中，44.8%未向存储库报告种族或族裔（平均入组人数 = 1481名参与者）。报告种族和族裔两者的研究比例从2013年的7.4%上升至2024年的54.6%。在多变量模型中，与干预性试验相比，观察性研究报告种族和族裔的几率较低（优势比[OR]=0.55，95%置信区间[CI]=0.49 - 0.61）。4期试验报告种族和族裔的可能性最小（OR = 0.32；CI = 0.29 - 0.35），与有任何行业资助或赞助的研究相比，仅由美国国立卫生研究院资助的研究更有可能报告种族和族裔（OR = 1.70，CI = 1.
