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Trial characteristics associated with the underrepresentation of women as lead authors in heart failure clinical trials




Clinical trials change practice in cardiology, and leading them requires research training, mentorship, sponsorship, and networking. Women report challenges in obtaining these opportunities.

The purpose of this review was to evaluate temporal trends in representation of women as authors in heart failure (HF) randomized controlled trials (RCTs) published in high-impact medical journals and explore RCT characteristics associated with women as lead authors.

We searched MEDLINE, EMBASE, and CINAHL for HF RCTs published in journals with an impact factor =10 between January 1, 2000, and May 7, 2019. We assessed temporal trends in the gender distribution of authors, and used multivariable logistic regression to determine characteristics associated with women as lead authors.

We identified 10,596 unique articles, of which 403 RCTs met inclusion criteria. Women represented 15.6% (95% confidence interval [CI]: 12.2% to 19.6%), 12.9% (95% CI: 9.8% to 16.6%), and 11.4% (95% CI: 8.5% to 14.9%) of lead, senior, and corresponding authors, respectively. The proportion of women authors has not changed over time. Women had lower odds of lead authorship in RCTs that were multicenter (odds ratio [OR]: 0.58; 95% CI: 0.18 to 0.96; p = 0.037), were coordinated in North America (OR: 0.21; 95% CI: 0.08 to 0.70; p = 0.011) or Europe (OR: 0.33; 95% CI: 0.09 to 0.91; p = 0.039), tested drug interventions (OR: 0.42; 95% CI: 0.16 to 0.97; p = 0.043), or had men as the senior author (OR: 0.50; 95% CI: 0.21 to 0.93; p = 0.043).

Women are under-represented as authors of HF RCTs, with no change in temporal trends. Women had lower odds of lead authorship in RCTs that were multicenter, were coordinated in North America or Europe, tested drug interventions, or had men as senior authors.

Acceptance Date Aug 26, 2020
Publication Date Oct 19, 2020
Journal Journal of the American College of Cardiology
Print ISSN 0735-1097
Publisher Elsevier
Pages 1919-1930
Keywords Heart failure, randomized controlled trials, authors, gender
Publisher URL