{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:44:37Z","timestamp":1786977877324,"version":"build-2736575974"},"reference-count":37,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,8,19]],"date-time":"2024-08-19T00:00:00Z","timestamp":1724025600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl Journal of Cancer"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Contemporary anticancer therapies frequently have different efficacy and side effects in men and women. Yet, whether women are well\u2010represented in pivotal trials supporting contemporary anticancer drugs is unknown. Leveraging the Drugs@FDA database,\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">clinicaltrials.gov<\/jats:ext-link>\n                    , MEDLINE, and publicly available FDA\u2010drug\u2010reviews, we identified all pivotal (phase II and III) non\u2010sex specific trials supporting FDA\u2010approval of anticancer drugs (1998\u20132018). Observed\u2010enrollment\u2010rates were compared to expected\u2010population\u2010rates derived from concurrent US\u2010National\u2010Cancer\u2010Institute's Surveillance\u2010Epidemiology\u2010and\u2010End\u2010Results (SEER) reported rates and US\u2010Census databases. Primary outcome was the proportional representation of women across trials, evaluated by a participation\u2010to\u2010prevalence ratio (PPR), according to cancer type. Secondary outcome was the report of any sex\u2010specific analysis of efficacy and\/or safety, irrespective of treatment\u2010arm. Overall, there were 148 trials, enrolling 60,216 participants (60.5\u2009\u00b1\u20094.0\u2009years, 40.7% female, 79.1% biologic, targeted, or immune\u2010based therapies) evaluating 99 drugs. Sex was reported in 146 (98.6%) trials, wherein 40.7% (24,538) were women, compared to 59.3% (35,678) men (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u2009.01). Altogether, women were under\u2010represented in 66.9% trials compared to the proportional incidence of cancers by respective disease type; weight\u2010average PPR of 0.91 (relative difference: \u20109.1%,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u2009.01). Women were most under\u2010represented in gastric (PPR\u2009=\u20090.63), liver (PPR\u2009=\u20090.71), and lung (PPR\u2009=\u2009.81) cancer trials. Sex\u2010based safety data was reported in 4.0% trials. There was no association between adequate female enrollment and drug efficacy (HR: 0.616 vs. 0.613,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u2009.96). Over time, there was no difference in the percentage of women recruited into clinical trials. Among pivotal clinical trials supporting contemporary FDA\u2010approved cancer drugs, women were frequently under\u2010represented and sex\u2010specific\u2010efficacy and safety\u2010outcomes were commonly not reported.\n                  <\/jats:p>","DOI":"10.1002\/ijc.35110","type":"journal-article","created":{"date-parts":[[2024,8,19]],"date-time":"2024-08-19T04:04:50Z","timestamp":1724040290000},"page":"1958-1968","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Representation of women in clinical trials supporting\n                    <scp>FDA<\/scp>\n                    \u2010approval of contemporary cancer therapies"],"prefix":"10.1002","volume":"155","author":[{"given":"Sujay","family":"Kalathoor","sequence":"first","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7205-1427","authenticated-orcid":false,"given":"Sanam","family":"Ghazi","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beryl","family":"Otieno","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"},{"name":"Department of Medicine Greater Baltimore Medical Center  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa A.","family":"Babcook","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"},{"name":"Division of Oncology James Cancer Hospital and Solove Research Institute at The Ohio State University  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunnia","family":"Chen","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neha","family":"Nidhi","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junu","family":"Bae","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jovan","family":"Pierre\u2010Charles","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khadijah","family":"Breathett","sequence":"additional","affiliation":[{"name":"Division of Cardiology Indiana University  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sula","family":"Mazimba","sequence":"additional","affiliation":[{"name":"Division of Cardiology University of Virginia  Charlottesville Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amber","family":"Johnson","sequence":"additional","affiliation":[{"name":"Division of Cardiology University of Pittsburgh School of Medicine  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"LaPrincess","family":"Brewer","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Mayo Clinic  Rochester Minnesota 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USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mussammat","family":"Ferdousi","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Onaopepo","family":"Kola\u2010Kehinde","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"McLaughlin","sequence":"additional","affiliation":[{"name":"Center for Biostatistics, Department of Biomedical Informatics The Ohio State University  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Brammer","sequence":"additional","affiliation":[{"name":"Division of Hematology James Cancer Hospital and Solove Research Institute at The Ohio State University  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Ruz","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Khan","sequence":"additional","affiliation":[{"name":"Cardio\u2010Oncology Program, Division of Cardiology The Ohio State University Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bismarck","family":"Odei","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology James Cancer Hospital and Solove Research Institute at The Ohio State University  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darrion","family":"Mitchell","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology James Cancer 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