{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T11:10:45Z","timestamp":1780917045271,"version":"3.54.1"},"reference-count":17,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,8,4]],"date-time":"2025-08-04T00:00:00Z","timestamp":1754265600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,8,4]],"date-time":"2025-08-04T00:00:00Z","timestamp":1754265600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["nyaspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ann NY Acad Sci"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\u201cGeneralizability\u201d refers to when trial results are applied to populations that did not participate in the trial. It is important when pre\u2010licensing trial results are used by regulators to authorize the use of a drug in different countries. To \u201cgeneralize\u201d the results, the trial sample must represent the population from which participants are drawn. They must also ensure that the trial will mimic usual clinical practice. Double\u2010blind, placebo\u2010controlled phase 3 trials are very different from usual practice. Investigators have flagged that samples from phase 3 trials of liraglutide, semaglutide, and tirzepatide excluded one\u2010third of US adults without diabetes who were eligible for weight loss. The authors advised caution on \u201cgeneralizing\u201d the results to populations excluded from these trials. However, they erroneously used \u201cgeneralizability\u201d when referring to \u201crepresentativeness.\u201d Similarly, in studies assessing whether real\u2010world populations from China, the United Kingdom, the United States, and Spain were represented in cardiovascular outcomes phase 3 trials in type 2 diabetes with dulaglutide, exenatide, liraglutide, and semaglutide, the authors used \u201cgeneralizability\u201d in the texts of the articles. The enrolled trial samples were not representative of the real\u2010world population: the term \u201cgeneralizable\u201d should not have been used. There is widespread confusion among investigators regarding the correct use of the term \u201cgeneralizability.\u201d<\/jats:p>","DOI":"10.1111\/nyas.70025","type":"journal-article","created":{"date-parts":[[2025,8,5]],"date-time":"2025-08-05T05:19:45Z","timestamp":1754371185000},"page":"15-18","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Generalizability of glucagon\u2010like peptide 1 receptor agonist clinical trial results to product labeling and the real world"],"prefix":"10.1111","volume":"1551","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0980-2486","authenticated-orcid":false,"given":"Rafael","family":"Dal\u2010R\u00e9","sequence":"first","affiliation":[{"name":"Epidemiology Unit, Health Research Institute\u2010Fundaci\u00f3n Jim\u00e9nez D\u00edaz University Hospital Universidad Aut\u00f3noma de Madrid  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,4]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/ebmed-2017-110800"},{"key":"e_1_2_9_3_1","volume-title":"A Dictionary of Epidemiology","author":"International Epidemiology Association","year":"2014"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.a2390"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/0021-9681(67)90041-0"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/jim-2021-001789"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejim.2018.04.022"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h2147"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2024.6340"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31149-3"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1612917"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1603827"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1607141"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13649"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-021-01079-x"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.14580"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-022-02196-0"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-019-02672-7"}],"container-title":["Annals of the New York Academy of Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/nyaspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/nyas.70025","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/nyaspubs.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/nyas.70025","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/nyaspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/nyas.70025","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T10:28:50Z","timestamp":1780914530000},"score":1,"resource":{"primary":{"URL":"https:\/\/nyaspubs.onlinelibrary.wiley.com\/doi\/10.1111\/nyas.70025"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,4]]},"references-count":17,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,9]]}},"alternative-id":["10.1111\/nyas.70025"],"URL":"https:\/\/doi.org\/10.1111\/nyas.70025","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.1111\/NYAS.70025\/v1\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/NYAS.70025\/v2\/response1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/NYAS.70025\/v2\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/NYAS.70025\/v1\/review1","asserted-by":"object"}]},"ISSN":["0077-8923","1749-6632"],"issn-type":[{"value":"0077-8923","type":"print"},{"value":"1749-6632","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,4]]},"assertion":[{"value":"2025-08-04","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}