Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Devices
Open accessAbstract
Background—: Cardiovascular devices can have different safety and effectiveness profiles in men and women. The type and quality of sex-specific data reviewed by the Food and Drug Administration (FDA) before approval of these devices are unknown. Methods and Results—: We performed a systematic review of the demographics, comments on gender bias, and analysis of results by sex for 78 high-risk cardiovascular devices that received premarket approval by the FDA between 2000 and 2007. FDA summaries of evidence did not report sex of enrollees in 34 (28%) of 123 studies. For studies reporting sex distribution, the study populations were, on average, 67% men. There was no increase in the enrollment of women over time. Explanations for the relatively low percentage of women often stated that the trials reflected either underlying disease distribution or referral rates for similar procedures or that the sex distribution reflected similar or previous trials. Forty-one percent of studies included a gender bias comment or analysis, and 12 (26%) of 47 of these analyses identified some difference in device safety or effectiveness by sex. Conclusions—: There is a lack of sex-specific safety and effectiveness data for high-risk cardiovascular devices before FDA approval. The justifications for this lack of evidence may perpetuate the status quo. More rigorous FDA requirements for sex-specific data before device approval could present an opportunity to improve cardiovascular outcomes.
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The majority (67%) of patients enrolled in clinical trials for cardiovascular devices are male.
“the majority (67%) of patients enroled in clinical trials for cardiovascular devices are male126.”
From Sex and gender differences and biases in artificial intelligence for biomedicine and healthcare (2020) · cites this paper as [126]
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Self-citation
- Authors
- Dhruva, S. S., Bero, L. A., & Redberg, R. F.
- Affiliations
- University of California, San Francisco (US)
- Venue
- Circulation: Cardiovascular Quality and Outcomes
- Published
- 2011-03
- Volume
- 4
- Issue
- 2
- Pages
- 165-171
- ISSN
- 1941-7705 (ISSN-L)
- 1941-7713
- OpenAlex
- W2117344524
- Cited by
- 87
- References
- 35
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 6 · 2023: 3 · 2022: 4 · 2021: 7 · 2020: 9 · 2019: 5 · 2018: 5 · 2017: 3 · 2016: 8 · 2015: 6 · 2014: 8 · 2013: 3 · 2012: 13
- FWCI
- 8.49
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Circulation Cardiovascular Quality and Outcomes (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Centre International de Recherche sur le Cancer
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Sex and Gender in Healthcare
- Social Sciences › Gender Studies › Diversity and Career in Medicine
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Keywords
- gender bias, sex differences, cardiovascular devices, FDA premarket approval, women in clinical trials, device safety and efficacy, sex-stratified analysis
- MeSH terms
- Cardiovascular Diseases, Clinical Trials as Topic, Female, Humans, Male, Prejudice, United States, United States Food and Drug Administration, Treatment Outcome, Device Approval, Cardiac Resynchronization Therapy Devices
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