Abstract 13205: Underrepresentation of Women as Clinical Trialists in Heart Failure: A Systematic Review of Randomized Controlled Trials Published in High-impact Medical Journals

Abstract

Introduction: Clinical trials change practice in cardiology but leading them typically requires advanced research training, mentorship, sponsorship, and networking. Women are underrepresented in cardiology and report challenges in obtaining mentorship and networking opportunities. Objective: To evaluate the gender distribution of first and senior authors in practice-changing clinical trials in heart failure (HF), and explore clinical trial characteristics associated with women as first authors. Methods: We searched MEDLINE, EMBASE and CINAHL databases for randomized controlled trials (RCTs) published January 2000 - May 2019. We included RCTs that recruited adults with HF with reduced ejection fraction that were published in medical journals with an impact factor of > 10. Two reviewers screened and extracted data independently. We determined the gender distribution of the authors, assessed temporal trends in authorship, and used logistic regression to identify characteristics associated with women in first authorship positions. Results: The search identified 10,596 unique studies, of which 317 met eligibility criteria. We found that 15.8%, 11.7%, and 10.7% of first, senior, and corresponding authors, respectively, were women. Multivariable analysis revealed that the first author was more likely to be a woman if the senior author of a clinical trial was a woman (odds ratio [OR] 2.17, 95% confidence interval [CI] 1.04-4.66, p=0.039), and if the trial was conducted at a single rather than multiple centers (OR 1.40, 95% CI 1.09-6.48, p=0.035). Source of funding (public or industry), type of intervention (health service, drug, device, or surgery), and region of trial coordination (Europe, North America, Central and South America, Asia, and Australia) were not associated with gender of first authors. The proportion of trials that included women as authors has decreased from 2000 to present. Conclusion: Women are under-represented as clinical trialists in HF. Adjusting for other trial characteristics, the first author of a clinical trial was more likely to be a woman if the senior author was a woman. Mentoring women as clinical trialists in the present era may be a strategic way to increase the gender diversity of clinical trialists in years to come.