Analysis of all 46 novel drugs the FDA approved in 2025 finds that enrollment in the trials behind them often did not reflect who lives with each disease; report lays out practical, bipartisan fixes
WASHINGTON , Sept. 30, 2026 /PRNewswire/ —
FINDINGS AT A GLANCE
46 drugs, about 26,000 participants. The report reviews every novel drug the FDA approved in 2025 and the pivotal trials behind them, using the FDA’s own Drug Trials Snapshots data.
- Most patients were studied abroad. In cancer trials and in heart, blood, kidney, and endocrine trials, only about 1 in 5 participants enrolled in the United States.
- Enrollment often did not match who has the disease. Black and Hispanic participation frequently fell below disease burden; in more than a third (38%) of trials reporting ethnicity, Hispanic patients were 5% or fewer of participants.
- Older adults were underrepresented. Adults 65+ were only about a quarter to a third of participants in cancer and cardiovascular trials, though those diseases concentrate in older patients.
- A telling example. A new multiple myeloma drug, for a cancer that strikes Black Americans at roughly twice the rate of White Americans, was tested in only about 11 Black patients.
- It can be done. Several 2025 trials enrolled the patients who have the disease, in rare and common conditions alike; one ultra-rare pediatric trial reached 36% Hispanic enrollment.
- The fixes are practical and bipartisan. Base enrollment goals on disease burden, set minimum numbers for key groups, report U.S. and non-U.S. enrollment separately, and remove travel and out-of-pocket costs that keep patients out of trials.
“A pivotal trial has one job: to show whether a drug works and is safe for the people who will take it,” said Dr. Jane L. Delgado, President and Chief Executive Officer of the Healthy Americas Foundation. “Too often in 2025 the evidence was gathered on patients who are not the ones the drug will treat. When a medicine does not work as expected, or causes harm, it is patients and their families who pay first, and the health system pays after them. The good news is that this is fixable, and several trials this year already show it can be done.”
The report released today shows that the necessary recruitment is achievable; recommends a set of practical steps, several of which already have bipartisan support in Congress; reviews the current federal landscape; and, includes a master table of all 46 approvals and participation levels of every reported group. The report is available at healthyamericasfund.org.
About The Healthy Americas Foundation®
The Healthy Americas Foundation® (HAF) seeks to improve the health of individuals and families throughout the Americas. For more information, please visit www.healthyamericasfund.org
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SOURCE Healthy Americas Foundation (HAF)
