Representation of Women in Cardiovascular Clinical Trial Leadership

Abstract

This quality improvement study describes representation of women within leadership committees of clinical trials and in lead authorship positions of ensuing cardiovascular trial publications.

It is well documented that women are underrepresented in leadership within academic medicine. In biomedical sciences, they account for almost half of postdoctoral fellows but only 19% of tenured senior investigators.¹ Cardiology lags behind other internal medicine specialties with regard to women entering the field and achieving leadership positions.² However, little is known about women in cardiovascular clinical trial leadership. In this study, we describe their representation within leadership committees of clinical trials, as well as in lead authorship positions of ensuing trial publications.

Methods

Because this quality improvement study did not involve patients, it was not subject to approval per the institutional review board specifications at the Cleveland Clinic. For this study, we included cardiovascular medicine publications presenting clinical trial results published in JAMA, The Lancet, and New England Journal of Medicine (NEJM) from January 1, 2014, to December 31, 2018. Leadership committees were identified from the publication or trial web page. Steering committees were obtained preferentially and included executive committees when listed separately. Executive committees were used if no steering committee was present. If neither were available, investigators listed under “primary contributors” or “study oversight” were used. These individuals are collectively referred to as leadership committees.

Data were analyzed from January 1, 2014, to December 31, 2018. We used Google searches to divide authors and leadership committee members by gender, as identified by photographs, gender pronouns, and presentation of self on institutional websites and social media. Gender grouping was confirmed by 2 reviewers (K.J.D. and N.S.).

Results

We identified 200 cardiovascular medicine trial publications during the study period, including 89 in NEJM, 41 in JAMA, and 70 in The Lancet. Steering and/or executive committees were used in 152 of 200 publications (76.0%). Primary contributors or study oversight committees were used in 48 of 200 studies (24.0%).

Of 2433 leadership committee members, 270 (11.1%) were women, with women representing a median of 10.1% (range, 0%-57.1%) of committees, including 9.4% for NEJM, 8.9% for The Lancet, and 13.9% for JAMA. Female physicians represented a mean of 5.4% to 6.3% of leadership committees. Among these 200 trials, 83 (41.5%) had no female investigators and 111 (55.5%) had no female physicians on their leadership committees (Figure). Only 19 of 200 trials (9.5%) included greater than 25% women in their leadership committees.

Figure. Proportion of Women as Cardiovascular Clinical Trial Investigators and in Leadership Committees.

NEJM indicates New England Journal of Medicine.

Women accounted for 18.5 of 200 first authors (9.3%) and 20 last authors (10.0%), ranging from 5 of 70 (7.1%) for The Lancet to 5 of 41 (12.2%) for JAMA for first authors and from 6 of 70 (8.6%) for The Lancet to 7 of 41 (17.1%) for JAMA for last authors. In large and procedurally oriented trials, even fewer women were represented in first and last author positions, with 2 (6.7%) JAMA to 4 (8.9%) NEJM first authors and 2 (4.3%) NEJM to 4 (13.3%) JAMA last authors (Table).

Table. Comparison of First and Last Authors by Journal.

Journal	No. of trials	No. (%) of trials with female authors
		First author	Last author
Total trials
JAMA	41	5 (12.2)	7 (17.1)
The Lancet	70	5 (7.1)	6 (8.6)
NEJM	89	8.5 (9.6)	7 (7.9)
Total	200	18.5 (9.3)	20 (10.0)
Large trialsa
JAMA	25	4 (16.0)	2 (8.0)
The Lancet	46	2 (4.3)	3 (6.5)
NEJM	77	7.5 (9.7)	6 (7.8)
Total	148	13.5 (9.1)	11 (7.4)
Procedural trialsb
JAMA	30	2 (6.7)	4 (13.3)
The Lancet	45	4 (8.9)	3 (6.7)
NEJM	47	2.5 (5.3)	2 (4.3)
Total	122	8.5 (7.0)	9 (7.4)

Abbreviation: NEJM, New England Journal of Medicine.

^aIndicates more than 500 participants.

^bIncludes those in the fields of interventional cardiology and electrophysiology.

Discussion

Analysis of the representation of women leaders in cardiovascular clinical trials revealed the following. First, women constituted only 10.1% of clinical trial leadership committees; this is substantially lower than the already low proportion of women physicians or investigators in the cardiovascular therapeutic area. Second, 55.5% of leadership committees had no female representation. Third, cardiovascular clinical trial publications had women in only 9.3% of the first or 10.0% of the last author position.

Our findings provide additional evidence of gender disparities in scientific leadership. Prior research suggests that research teams with gender heterogeneity may produce higher quality research.³ Greater visibility of women in clinical trial leadership positions can enhance recruitment of female trial participants and attract more female investigators to cardiovascular clinical research. Although we did not study causality, unconscious biases may lead to discrimination in clinical trial leader selection on the basis of gender.⁴ A vicious cycle has been observed for women in academic medicine, with the exclusion of women leading to further exclusion, lack of recognition, and slow rates of promotion.⁵ Many of these factors are likely contributory; this disparity and lack of inclusion is a multifactorial problem that warrants further research.

This study has limitations, including human error in gender determination and a binary gender system. Authorship and trial committees are components of leadership and may overestimate or underestimate the true presence of women in clinical trial leadership roles.