Analysis of Female Participant Representation in Registered Oncology Clinical Trials in the United States from 2008 to 2020
| Autor: | Perera, Nirosha D, Bellomo, Tiffany R, Schmidt, Walker M, Litt, Henry K, Shyu, Margaret, Stavins, MaKenna A, Wang, Max M, Bell, Alexander, Saleki, Massoud, Wolf, Katherine I, Ionescu, Ruxandra, Tao, Jacqueline J, Ji, Sunjong, O'Keefe, Ryan M, Pun, Matthew, Takasugi, Jordan M, Steinberg, Jecca R, Go, Ronald S, Turner, Brandon E, Mahipal, Amit |
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| Rok vydání: | 2023 |
| Předmět: |
Male
female participant representation Clinical Trials and Supportive Activities Oncology and Carcinogenesis participation to prevalence ratio oncology clinical trials Medical Oncology United States Databases Clinical Research Neoplasms Prevalence Odds Ratio Humans Female Oncology & Carcinogenesis Digestive Diseases Factual Cancer |
| Zdroj: | The oncologist, vol 28, iss 6 |
| Popis: | BackgroundFemale underrepresentation in oncology clinical trials can result in outcome disparities. We evaluated female participant representation in US oncology trials by intervention type, cancer site, and funding.Materials and methodsData were extracted from the publicly available Aggregate Analysis of ClinicalTrials.gov database. Initially, 270,172 studies were identified. Following the exclusion of trials using Medical Subject Heading terms, manual review, those with incomplete status, non-US location, sex-specific organ cancers, or lacking participant sex data, 1650 trials consisting of 240,776 participants remained. The primary outcome was participation to prevalence ratio (PPR): percent females among trial participants divided by percent females in the disease population per US Surveillance, Epidemiology, and End Results Program data. PPRs of 0.8-1.2 reflect proportional female representation.ResultsFemales represented 46.9% of participants (95% CI, 45.4-48.4); mean PPR for all trials was 0.912. Females were underrepresented in surgical (PPR 0.74) and other invasive (PPR 0.69) oncology trials. Among cancer sites, females were underrepresented in bladder (odds ratio [OR] 0.48, 95% CI 0.26-0.91, P = .02), head/neck (OR 0.44, 95% CI 0.29-0.68, P < .01), stomach (OR 0.40, 95% CI 0.23-0.70, P < .01), and esophageal (OR 0.40 95% CI 0.22-0.74, P < .01) trials. Hematologic (OR 1.78, 95% CI 1.09-1.82, P < .01) and pancreatic (OR 2.18, 95% CI 1.46-3.26, P < .01) trials had higher odds of proportional female representation. Industry-funded trials had greater odds of proportional female representation (OR 1.41, 95% CI 1.09-1.82, P = .01) than US government and academic-funded trials.ConclusionsStakeholders should look to hematologic, pancreatic, and industry-funded cancer trials as exemplars of female participant representation and consider female representation when interpreting trial results. |
| Databáze: | OpenAIRE |
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