Women notably underrepresented in clinical trial leadership

Women appeared significantly underrepresented as first authors of thousands of randomized controlled trials compared with men, according to study results published in Contemporary Clinical Trials.

The findings indicate a need for increased efforts toward inclusion of women as leaders of clinical trials, researchers concluded.

“It has been established that identity of the trial leadership plays a role in the conduct of the trial,” Bharat Rawlley, MBBS, resident in the department of internal medicine at SUNY Upstate Medical University, and colleagues wrote. “An estimation of the gender composition of randomized controlled trial leadership in India has not been undertaken. We performed this study to quantify the gender composition of first authors of clinical trials.”

Invisible female scientists

As Healio previously reported, women continue to be underrepresented as leaders in clinical research and in clinical trials in particular.

“Female scientists are similarly invisible in some institutions, with persistent gaps in salary support, access to research data, protected research time, invitations to networking events, nominations for awards and research chairs, mentorships, sponsorship and even respect in the workplace,” Harriette Van Spall, MD, MPH, associate professor in the division of cardiology at McMaster University and scientist with the Population Health Research Institute in Ontario, Canada, said during a presentation at the most recent American Heart Association Scientific Sessions.

In an analysis of 403 randomized clinical trials published from 2000 to 2019, Van Spall and colleagues found that women represented 15.6%, 12.9% and 11.4% of lead, senior and corresponding authors, respectively.

“Women had lower odds of lead authorship in trials that were multicenter, were coordinated in North America or Europe, tested drug interventions, or had men as senior authors,” Van Spall said. “However, trials with women as senior leaders had twice the odds of women as first authors.”

Persisting gender disparities

In the current analysis, Rawlley and colleagues pooled data from the PubMed database and identified 4,056 randomized controlled trials that contained information on first-author affiliation published between Jan. 1, 2011, and Dec. 31, 2020.

According to study results, only 30% (n = 1,198) of randomized-controlled trials included women as first authors compared with 70% (n = 2,858) of trials with men as first authors.

Researchers additionally reported mean percentages of yearly distribution of first authors of 30% for women vs. 70% for men. Of note, researchers did not observe significant changes in gender distribution of first authors during the study period (P = .78).

“The persistence of gender disparity in the leadership of randomized controlled trials from India demands greater efforts toward inclusion of women as leaders of clinical trials,” Rawlley and colleagues wrote.

Efforts underway

In an effort to increase representation of women in research, the V Foundation recently announced a multimillion dollar inaugural program dubbed A Grant of Her Own: The Women Scientists Innovation Award for Cancer Research.

The program aims to address gender inequities in cancer research funding.

“By providing self-identified female investigators the necessary resources to begin and sustain impactful research and careers, [the program] will help address systemic gender disparities which have long existed and were further widened during the pandemic,” Susanna F. Greer, PhD, chief scientific officer of V Foundation, said in a press release. “These factors have kept women from fully contributing to the field of cancer research.”

The deadline for candidate applications is March 16, 2023.

References :

• Rawlley B, et al. Contemp Clin Trials. 2023;doi:10.1016/j.cct.2023.107081.
• Van Spall HCG. Annual Dr. Nanette K. Wenger Research Goes Red Award for best scientific article on cardiovascular disease and stroke in women. Presented at: American Heart Association Scientific Sessions; Nov. 5-7, 2022; Chicago (hybrid meeting).