Approved-Label Populations for New Drugs Broader Than Trial Populations
TUESDAY, July 15, 2025 -- Approved label populations for new drugs are broader than trial populations overall, according to a study published online July 8 in the Annals of Internal Medicine.
Kerstin N. Vokinger, M.D., J.D., Ph.D., from the University of Zurich, and colleagues conducted a cross-sectional study to examine the differences in the characteristics of enrolled patients between trial populations and approved-label populations in the United States, European Union, and Switzerland. The study included all new drugs approved by three regulatory agencies from 2012 to 2023. The eligibility criteria of the trial population were compared to those of the approved-label population for five categories: age, disease subtype, disease severity, patient fitness, and prior therapy.
The study cohort included 263 drugs (278 indications). The researchers found that approved-label populations were broader than trial populations overall, and these findings were more pronounced in the United States. Inconsistency was seen most often in terms of patient fitness, with 276 and 275 approved indications in the United States and European Union and in Switzerland (99.3 and 98.9 percent), respectively, followed by disease severity, with 143, 119, and 111 approved indications in the United States, European Union, and Switzerland, respectively (51, 43, and 40 percent).
"It could be helpful for patients and physicians if the regulatory agencies specified to what extent the approved-label population is congruent with the trial population," the authors write.
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