Assessing Equity and Representativeness in Randomised Controlled Trials: A Feasibility Study

Clinical trials often enrol populations that differ from those who ultimately receive the interventions, raising concerns about external validity and health equity. Trial registries could provide an early opportunity to assess representativeness, but it is unclear whether registry data contain sufficient information to enable such assessments. This study evaluated the feasibility of using registry data to assess representativeness in Phase II and III pharmacological randomised controlled trials. A search of ClinicalTrials.gov from December 2024 to January 2025 identified trials with results posted after 1 January 2023 across cardiovascular disease (CVD) excluding stroke, diabetes mellitus, and selected mental health disorders. Of 1,328 records screened, 98 trials met inclusion criteria (51 Phase III, 47 Phase II). Reporting completeness was variable, particularly in Phase II studies. CVD and diabetes trials predominantly included middle-aged to older adults, while mental health trials recruited mainly individuals aged 36 to 50 years. Across CVD and mental health trials, participants were largely male. Reporting of BMI, contraception, and comorbidity criteria was inconsistent, though available data suggested these factors influenced sample composition. Fewer than 10% of trials reported equity-relevant characteristics beyond age and sex, and none addressed intersectionality. Assessing equity using registry data is feasible but constrained by incomplete and inconsistent reporting.