Countries Involved in U.S. Clinical Trials Do Not Gain Timely Access to Approved Medicines

WEDNESDAY, Nov. 19, 2025 (HealthDay News) — Most countries involved in clinical trials for U.S. Food and Drug Administration approvals do not gain timely physical access to the medicines that they help evaluate, according to a study published online Nov. 17 in JAMA Internal Medicine.

Chris J. Lee, from Yale University in New Haven, Connecticut, and colleagues assessed whether and when medicines received market authorization (i.e., become physically accessible) in the countries where they were tested for FDA approval. The analysis included data from 885 phase 2 and 3 trials supporting FDA approval of 172 novel medicines from 2015 to 2018 (89 countries).

The researchers found that among the 77 countries publicly reporting marketing authorizations, 11 had physical access to all of the medicines they tested within five years of FDA approval. Of the 144 medicines tested outside the United States, just under one-quarter (24 percent) were physically accessible in all countries where they were tested. Greater physical access was seen in high-income countries, with 45 of 142 (32 percent) tested medicines being physically accessible. For upper-middle-income and lower-middle-income countries, 22 percent and 13 percent of tested medicines were physically accessible within five years of FDA approval, respectively. Physical access of tested medicines was lowest in Africa (11 of 40) and highest in Western Europe (104 of 127). Over time, physical access improved for high-income countries (2015-2016 versus 2017-2018: 22 versus 38 percent), but there were no statistically significant improvements for upper-middle-income (18 versus 24 percent) or lower-middle-income countries (14 versus 12 percent).

“This gap raises concerns,” lead author Jennifer E. Miller, Ph.D., also from Yale, said in a statement. “According to ethical guidance, if you enroll a population in clinical research, they must stand to benefit from it.”

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