Closing the Gender Gap in Cardiology Clinical Trial Leadership: A Road Map

Women are conspicuously absent as leaders of cardiovascular clinical trials—now, an “actionable road map” aims to rectify this imbalance by itemizing the core competencies required to lead a clinical trial, and by offering concrete steps that institutions, professional societies, industry, and public funding agencies can take to ensure clinical trials get more female principal investigators and chairs.

“We must adopt transformative strategies to harness the strengths of women as CV clinical trial leaders and deconstruct the sexism that has been normalized in the clinical trial enterprise,” the authors write. “For far too long, recruitment, advancement, mentorship, and sponsorship have followed gender lines, with decisions generally made by men for men.”

The document, led by Harriette Van Spall, MD (McMaster University/Population Health Research Institute, Hamilton, Canada), was published online this week in the Journal of the American College of Cardiology.

Cardiology’s gender gap has been highlighted in a range of recent studies looking at fellowships, first authors, senior authors, full professorships, and the choice to pursue cardiology or interventional cardiology as a specialty from the outset. Cardiology clinical trial leadership suffers from the same problem. As Van Spall and co-authors point out, research published last year covering a recent 4-year period indicates that more than half of cardiovascular clinical trials published in the big three medical journals (Lancet, JAMA, and New England Journal of Medicine) lacked women on their steering committees and only one in ten were led by female principal investigators. 

The current viewpoint, Van Spall told TCTMD, “represents a move from calling out a problem to solving it in a very constructive way. What we lay out are checklists that institutions can use to track progress, to report progress, and to move to the next phase to completely close the gap.”

A Multipronged Approach

Van Spall and colleagues review the rationale for ending gender inequality in research, pointing out that diverse leadership in randomized clinical trials has been shown to benefit both professionals and patients. Notably, trials led by women tend to enroll more female, Black, Indigenous, and people of color, they note, leading to results that more accurately reflect the makeup of most physician practices.

The document goes on to describe the specific “competencies” required of physicians seeking to lead clinical trials in cardiology, itemized with an eye toward early career/physicians-in training.

Next, the paper addresses the critical role played by academic institutions and, again, provides a checklist of steps universities and teaching hospitals can take to improve the representation of women as trial leaders.

“There are things that academic institutions need to do to close the gaps, through the purposeful recruitment, retention, and [provision of] internal opportunities that allow for advancement based on merit, rather than informal networks that are often the basis of career progression,” Van Spall explained. “Academic institutions are highly politically charged, and you can be exceptional but not belong to a network that is going to lift you.”

“Catalyzer” organizations are important advocates for female leaders, the document notes, but responsibility for ending gender inequality also falls to professional societies, trial leadership selection committees, funding bodies, medical journals, and ultimately individual scientists themselves, each of which are dealt with in turn by the paper, with itemized calls to action.

In recent years, professional societies and their affiliated meetings and medical journals have made strides in closing the gender gap, but industry—which funds the lion’s share of cardiovascular clinical trials—has a lot of ground to make up.

“We’ve seen through multiple studies of ours that industry-led trials are definitely less likely to have women and diverse representation among trial leadership, and the path to leading an industry-sponsored trial is quite unclear,” Van Spall said. “It relies heavily on being part of certain networks that are really not open. And so this is a call for our industry partners, who we value and we rely on for innovation and interventions that help our patients: we're calling them to step up with us and to harness the energy and the potential and the enthusiasm and the skills that we have to diversify the face of leadership.” Several co-authors on the paper, she added, were from industry. Van Spall hopes that as industry boards increase the number of female members, this may ultimately help increase awareness about the lack of diversity among clinical trial leaders.

But the “wait-and-see” approach has not necessarily achieved what many had hoped, Van Spall cautioned: hence, the rationale for a paper like this one that sets out clear and concrete steps for individuals and groups to follow.

“We haven't seen the trends change over the last 20 years, which is why this document is so focused on actually creating that change,” she stressed. “Because time alone, conversations alone, highlighting gaps alone will not bring that change [or tell us] what we need to do from here.”

Contacted for comment, a spokesperson for PhRMA, the trade group representing the US pharmaceutical industry, said the organization is actively working to improve gender, ethnic, and racial diversity in the drug development process.

“As part of our effort toward better representation, our industry made a commitment to being part of this change through the PhRMA Equity Initiative, which seeks to build career opportunities for emerging talent, improve health equity, and enhance clinical trial diversity in Black and Brown communities,” Sarah Sutton, PhRMA’s director of public affairs, said in an email. “PhRMA’s member companies voluntarily adopted principles on enhancing clinical trial diversity in October that took effect in April. PhRMA also just hosted a large-scale stakeholder workshop intended to identify partnerships and actionable next steps for sustainable clinical trial diversity.” 

And while men have an important role to play in advocating for diversity, Van Spall believes championing women as clinical trial leaders doesn’t have to mean stepping aside.

“We need to envision this not as any one group giving up their role, but on creating more roles and inviting more people to the table,” she said. “There are not a finite number of seats at the table. We need to create more seats so that we can make room for people who are capable, who have the skill set, and who can generate funds for research to lead the research.”