Women have been under-represented as professionals in cardiology and as researchers. In a systematic review of randomized clinical trials published in high impact journals, we assessed the gender distribution of authors of clinical trials in Heart Failure, and identified trial characteristics that were associated with women as lead (first) authors.

The leadership of a clinical trial is important for the running of trials but also for the career of the leaders as they often go on to lead or be involved in other clinical trials and are invited to sit at decision making tables regarding policy and implementation.

Among the 403 clinical trials analysed, 16% of lead authors, 13% of senior authors, and 11% of corresponding authors were women. These positions represent the key leadership positions in a clinical trial. Among a total of 4346 authors or co-authors in these trials, women comprised less than 20%. The proportion of women in these positions has not changed in 20 years.

After correcting for multiple factors, women had lower odds of lead authorship in trials that were led in North America or Europe, that involved multiple centers, that tested drug interventions, or that had men as the senior author. The odds of woman as first author were twice as high if the senior author was a woman rather than a man. This tells us that research networking and mentorship may follow gender lines. A strategic way to bring women into the fold as leaders of clinical trials is to ensure fair opportunities and support for women who are currently leading clinical trials.

Why is it important that women lead clinical trials in cardiology?

  • To increase women as participants in trials

Clinical trials with women as lead authors / investigators are associated with increased enrolment of women as trial participants, which is important because women are historically underrepresented as participants in cardiovascular clinical trials.

  • To increase the visibility of women role models and mentors to women trainees

Women are underrepresented in cardiology and women trainees perceive the field of cardiology to lack the mentors they desire. The vast majority of people presenting clinical trial results and receiving media attention for research are men, which leaves an impression on the minds of trainees that clinical trials are the domain of men.

  • To promote research into questions and diseases of particular importance to women patients
  • To increase representation and diversity at decision-making tables for policy and implementation

 

Why do women remain underrepresented as leaders of clinical trials?

Leading research requires advanced research training, mentorship, sponsorship, networking, and typically, academic appointments at research institutes. Women report that they obtain these opportunities less frequently than men, and certainly our results highlight that networking and mentorship may occur along gender lines.

Women also report inhospitable environments at research institutes and unequal opportunities for research salary support, funding, and leadership. These inequities deter women who are considering research careers and limit the success of women who remain in research careers, thereby depriving younger investigators the opportunity to be mentored by senior women. Another big factor is that women are under-represented in cardiology and this is what typically feeds the flow of women into cardiology subspecialties such as Heart Failure and into cardiology research; the under-representation in cardiology, however, doesn’t explain the gender association between lead and senior author.

What needs to be done?

The association we see between the gender of lead and senior author, after adjusting for other factors, implies that women leading clinical trials may help grow the career of other women in research. It may be that women junior investigators are more likely to be mentored and introduced into informal and formal networks by women senior investigators or that they see that a research career may be feasible despite the juggling required to manage clinical work and research in cardiology. While we did not test what interventions will improve these rates, our findings suggest that supporting the retention and career growth of existing women clinical trialists is a strategic way to grow the careers of a new generation of women clinical trialists.

Ways to facilitate this include:

  • encouraging early career cardiologists to invest in research training and to join research networks and enroll in registries that offer research collaboration
  • advising senior researchers to mentor, sponsor, and include women in research networks
  • requiring academic and departmental leaders to participate in anti-bias training and implement objective criteria for research funding, promotion, advancement, and leadership
  • requiring institutions to equal research salary support and opportunity for men and women and to adopt zero tolerance policies for bullying and harassment
  • mandating journals and granting agencies to provide reviews blinded to the authors

 

Harriette Van Spall is Associate Professor of Medicine, Cardiologist, and Clinicial Trialist at McMaster University.

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