FDA Drug Trials Often Fail to Match Patient Demographics

The report from the Healthy Americas Foundation analyzed data from approximately 26,000 trial participants, uncovering systemic gaps in recruitment. In cancer and cardiovascular trials, only one in five participants were enrolled within the United States, and older adults—who bear the brunt of these chronic conditions—comprised only 25% to 33% of the study cohorts. The disparity is particularly sharp in oncology; for instance, a multiple myeloma treatment was tested on only 11 Black patients, even though the disease impacts Black Americans at twice the rate of White Americans.

Dr. Jane L. Delgado, CEO of the Healthy Americas Foundation, emphasized that the primary purpose of a trial is to ensure safety and efficacy for the eventual end-user. When clinical evidence fails to reflect the real-world patient base, families and the healthcare system bear the subsequent risks. However, the report highlights that these gaps are not inevitable, pointing to specific 2025 trials that successfully achieved representative enrollment. To bridge this divide, the foundation proposes bipartisan policy changes, including setting enrollment goals based on disease burden, establishing minimum participation quotas for key demographic groups, and eliminating financial or logistical barriers such as travel costs that currently deter potential participants.