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

Mamas

Abstract

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

Objectives
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.

Methods
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.

Results
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).

Conclusions
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.

Citation

Mamas. (2020). Trial characteristics associated with the underrepresentation of women as lead authors in heart failure clinical trials. Journal of the American College of Cardiology, 1919-1930. https://doi.org/10.1016/j.jacc.2020.08.062

• 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
• DOI: https://doi.org/10.1016/j.jacc.2020.08.062
• Keywords: Heart failure, randomized controlled trials, authors, gender
• Publisher URL: https://doi.org/10.1016/j.jacc.2020.08.062