Racial and ethnic diversity in clinical studies reported to ClinicalTrials.gov, 2009–2024
Year: 2026
Type: article
Abstract: Objective: 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. Our objectives are: (1) to identify study characteristics associated with reporting race and ethnicity of clinical study participants and (2) to document temporal trends in race and ethnicity reporting on ClinicalTrials.gov. Design: Cross-sectional analysis of interventional trials and observational studies from 2009 to 2024; multivariable logistic regression assessed study-level factors associated with reporting race and ethnicity. Setting: Global registry of clinical studies (ClinicalTrials.gov). Participants: 58 163 studies with posted results and without early termination. Exposures: Study characteristics: sponsor trial phase, study type and country. Main outcomes and measures: Reporting of race, reporting of ethnicity, reporting of both. Results: Among 58163 studies (mean enrolment=1215 participants), 44.8% did not report race or ethnicity to the repository (mean enrolment=1481 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 (OR 0.55, 95% CI 0.49 to 0.61) compared with interventional trials. Phase 4 trials were least likely phase to report race and ethnicity (OR=0.32; 95% CI 0.29 to 0.35), and studies with only National Institute of Health funding were more likely to report race and ethnicity compared with studies with any industry funding or sponsorship (OR=1.70, 95% CI 1.61 to 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. Conclusions: Race and ethnicity reporting on ClinicalTrials.gov has improved markedly yet remains incomplete, with shortfalls in late-phase and observational studies.
Source: UNC Libraries
DOI: 10.17615/4edt-3340
Institution: University of North Carolina at Chapel Hill
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: Nuffield Department of Population Health, University of Oxford, Deanship of Scientific Research, King Khalid University, Wetenschappelijk Fonds Willy Gepts, Universitair Ziekenhuis Brussel, Leona M. and Harry B. Helmsley Charitable Trust, Wellcome Trust, University of Manitoba, Natural Science Foundation of Guangxi Zhuang Autonomous Region, Innovative Research Group Project of the National Natural Science Foundation of China, Cambia Health Foundation, Bethune Charitable Foundation, Shanghai Municipal Health Commission, Stichting Kwaliteitsgelden Medisch Specialisten, Moderna, Children's Hospital Association, South African Medical Research Council, Deutsche Forschungsgemeinschaft, National Natural Science Foundation of China, Shanghai Municipal Education Commission, Natural Science Foundation of Guangdong Province, Guangxi Zhuang Region Health Department, Korea Health Industry Development Institute, Korea Institute of Oriental Medicine, National Research Foundation of Korea, Natural Science Foundation of Hubei Province, Princess Nourah Bint Abdulrahman University, Natural Science Foundation of Ningxia Province, Beijing University of Chinese Medicine, Kermanshah University of Medical Sciences, Lanzhou Science and Technology Bureau, Université de Montpellier, Frimodt-Heineke Fonden, Education Department of Jilin Province, Tianjin Municipal Education Commission, Alborz University of Medical Sciences, Medical Scientific Research Foundation of Zhejiang Province, China, Southwest Medical University, Guangdong Provincial Bureau of Quality and Technical Supervision, Kementerian Pendidikan Malaysia, Quzhou Municipal Science and Technology Bureau, Luzhou Science and Technology Bureau, Health Commission of Jiangxi Province, National Institutes of Health, Sichuan Province Science and Technology Support Program, Max Rady College of Medicine, University of Manitoba, Natural Science Foundation of Anhui Province, Industry-Academic Cooperation Foundation of Kyungnam University, South African Agency for Science and Technology Advancement, Medical Science and Technology Foundation of Guangdong Province, Postdoctoral Research Foundation of China, National Key Research and Development Program of China, West China Hospital, Sichuan University, Shenzhen Science and Technology Innovation Program, Basic and Applied Basic Research Foundation of Guangdong Province, National Center for Advancing Translational Sciences, Natural Science Foundation of Zhejiang Province
OpenAlex ID: W7163661093