{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T15:49:08Z","timestamp":1790264948833,"version":"4.1.0"},"reference-count":34,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,8,31]],"date-time":"2025-08-31T00:00:00Z","timestamp":1756598400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:p>Trial populations that are representative of the intended population for therapies build evidence supporting the generalizability of results to the intended population and improve adoption of novel therapies upon approval. We evaluated the demographic composition of trial populations in 62 pivotal studies supporting approval of novel therapies for human immunodeficiency virus, migraines, multiple sclerosis, and type 2 diabetes. Enrollment at all sites, US sites, and sites outside the United States was evaluated relative to US prevalence. Enrollment of Asian participants relative to US prevalence varied across evaluated drug programs. In most cases, enrollment of Black or African American participants across all sites combined was below disease prevalence. Enrollment for White participants was consistently above disease prevalence. For most programs, Hispanic or Latino participant enrollment met or approximated disease prevalence. For females, enrollment met or exceeded US prevalence in more than half of the therapies evaluated. Enrollment of Black or African American, White, and Hispanic or Latino participants from US sites in most trials approximated or exceeded US disease prevalence, whereas enrollment of Asian participants at US sites was generally below disease prevalence. Across evaluated trials, enrollment relative to disease prevalence varied at sites inside the United States compared to non\u2010US sites for Black and Asian participants. Enrollment by ethnicity, sex, or age group was generally similar for US and non\u2010US sites. Considering the demographics of countries where trial sites are located across development programs may enhance the ability to recruit participants that meaningfully reflect the population that would use therapies if approved.<\/jats:p>","DOI":"10.1002\/cpt.3578","type":"journal-article","created":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T06:28:51Z","timestamp":1756708131000},"page":"1213-1224","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Analysis by Age, Sex, Race, and Ethnicity of Participants in Clinical Trials Supporting Recently Approved Novel Therapies"],"prefix":"10.1002","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-3585-6963","authenticated-orcid":false,"given":"Neali H.","family":"Lucas","sequence":"first","affiliation":[{"name":"Office of the Commissioner U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinzhong","family":"Liu","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aden","family":"Asefa","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariel S.","family":"Armstrong","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary Thanh","family":"Hai","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,31]]},"reference":[{"key":"e_1_2_12_1_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2822"},{"key":"e_1_2_12_2_1","doi-asserted-by":"crossref","unstructured":"Federal Register Volume 63 Issue 28 (Wednesday February 11 1998).","DOI":"10.1016\/S1092-051X(00)80103-6"},{"key":"e_1_2_12_3_1","unstructured":"Food and Drug Administration Safety and Innovation Act (FDASIA) Public Law No. 112\u2010144 \u00a7 907(2012)."},{"key":"e_1_2_12_4_1","unstructured":"Food and Drug Administration Center for Drug Evaluation and Research.Drug trials snapshots<https:\/\/www.fda.gov\/drugs\/drug\u2010approvals\u2010and\u2010databases\/drug\u2010trials\u2010snapshots> Accessed December 20 2023."},{"key":"e_1_2_12_5_1","unstructured":"Food and Drug Administration Center for Drug Evaluation and Research.Drug trials snapshots summary report 2015\u20102019: five\u2010year summary and analysis of clinical trial participation and demographics<https:\/\/web.archive.org\/web\/20230127052325\/> and <https:\/\/www.fda.gov\/drugs\/drug\u2010approvals\u2010and\u2010databases\/drug\u2010trials\u2010snapshots> (November2020)."},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.16680"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/jcpt.13532"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.28809"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2021005482"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvh.13901"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000003478"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.02.070"},{"key":"e_1_2_12_13_1","unstructured":"Centers for Disease Control and Prevention.HIV surveillance report; 32 <https:\/\/stacks.cdc.gov\/view\/cdc\/149036> (2019)."},{"key":"e_1_2_12_14_1","unstructured":"National Center for Health Statistics.National health interview surveyCenters for Disease Control and Prevention <https:\/\/ftp.cdc.gov\/pub\/Health_Statistics\/NCHS\/NHIS\/SHS\/2018_SHS_Table_A\u20105.pdf> (2018). 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