Ten-Year Trends in Enrollment of Women and Minorities in Pivotal Cardiometabolic Trials

This analysis examined ten years of FDA pivotal trial data — 296,000 participants across cardiometabolic drug approvals — to ask how well women and racial minorities were represented in the evidence base that supported drug approval.

Women made up 36 percent of participants overall, but were measurably underrepresented relative to their share of disease burden in trials for coronary disease and acute coronary syndrome. Black participants represented 4 percent of the total; Asians 12 percent. No significant improvement occurred over the decade studied.

The finding is both structural and consequential. Drug approvals proceed on the assumption that efficacy and safety data applies broadly — but if the trial population skews heavily toward white men, precision is lost for everyone else. For cardiometabolic disease, where risk profiles and treatment responses vary meaningfully by sex and race, the gap is not merely academic.

We rate the evidence moderate. A rigorous audit of a large trial database, it documents a persistent enrollment problem with meaningful implications for the generalizability of current treatment guidelines to women and racial minorities.