Inclusion of minorities and women in cancer clinical trials, a decade later: have we improved?
Open accessAbstract
BACKGROUND: Inclusion of diverse groups of participants in cancer clinical trials is an important methodological and clinical issue. The quality of the science and generalizability of results depends on the inclusion of study participants who represent all populations among whom these treatment and prevention approaches will be used. METHODS: We conducted a systematic review using OVID as the primary source of reports included. Based on 304 peer-reviewed publications, diversity in the inclusion and reporting of study participants during a decade of cancer treatment and prevention trials (2001-2010) is summarized. Recommendations are made for improvements in the science and reporting of cancer clinical trials. RESULTS: Of the 277 treatment trials and 27 prevention trials included in this report, more than 80% of participants were white and 59.8% were male. In the recent decade, race and sex are rarely used as selection criteria unless the trial is focused on a sex-specific cancer. CONCLUSIONS: Women and racial/ethnic minorities remain severely underrepresented in cancer clinical trials, thus limiting the generalizability of cancer clinical research.
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Only 6% of patients with cancer enroll in clinical trials, and race-, sex-, and age-based disparities persist.
“only 6% of patients with cancer enroll in clinical trials (144) and there continue to be race-, sex-, and age-based disparities within clinical trials (145, 146).”
From Artificial Intelligence in Oncology: Current Landscape, Challenges, and Future Directions (2024) · cites this paper as [146]
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- Authors
- Kwiatkowski, K., Coe, K., Bailar, J. C., & Swanson, G. M.
- Affiliations
- Indiana University – Purdue University Indianapolis (US)
- University of Chicago (US)
- Corresponding author
- Swanson, G. Marie
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2013-05-14
- Volume
- 119
- Issue
- 16
- Pages
- 2956-2963
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- OpenAlex
- W1949221783
- Cited by
- 240
- References
- 15
- Citations by year
- 2026: 7 · 2025: 18 · 2024: 27 · 2023: 20 · 2022: 20 · 2021: 19 · 2020: 68 · 2019: 9 · 2018: 15 · 2017: 12 · 2016: 10 · 2015: 6 · 2014: 7 · 2012: 1
- FWCI
- 7.82
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Cancer (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Purdue University
- Indiana University-Purdue University Indianapolis
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Gender Studies › Diversity and Career in Medicine
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Sex and Gender in Healthcare
- Keywords
- underrepresentation of minorities, women in clinical trials, cancer clinical trials, racial and ethnic minorities, generalizability of trial results, cancer prevention trials
- MeSH terms
- Adult, Clinical Trials as Topic, Female, Humans, Middle Aged, Minority Groups, Neoplasms
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