A feasibility audit of 98 Phase II and III pharmacological randomised controlled trials — drawn from 1,328 ClinicalTrials.gov records screened between December 2024 and January 2025 — found that fewer than 10% reported equity-relevant characteristics beyond age and sex, and zero trials addressed intersectionality. CVD and diabetes trials skewed toward middle-aged to older adults; CVD and mental health trials enrolled predominantly male participants. Reporting of BMI, comorbidity criteria, and contraception requirements was inconsistent across registries, constraining any systematic representativeness assessment.
This preprint, not yet peer-reviewed, surfaces a structural problem that has long shadowed evidence-based medicine: trial populations routinely diverge from the real-world patients who ultimately receive approved therapies. When demographic data are missing at the registry level — before a trial even completes — clinicians and policymakers lose an early warning system for generalizability failures. The finding that no trial addressed intersectionality is particularly striking given two decades of health equity scholarship demonstrating compounding disadvantages across race, sex, socioeconomic status, and comorbidity. The study's scope is limited to a single registry snapshot and three disease categories, so broader conclusions require caution. Nevertheless, the audit reinforces calls for mandatory structured equity reporting in registry submissions — a regulatory lever that FDA and EMA have moved toward but not yet standardized. If confirmed through peer review, this work argues less for new science than for disciplined data infrastructure as a prerequisite for equitable medicine.