Commentary: A Lack Of Diversity Among Clinical-Trial Regulators Puts Women’s Lives At Risk

This commentary was sponsored by YPO.

The pandemic has brought to light the many inequities in access to testing, vaccines and care for COVID-19.

And governments around the world have been paying new attention to the gender health gap. Vice President Kamala Harris just spoke about how women’s access to quality healthcare makes it harder for women to participate in decision-making and ultimately, for Democracies to thrive. Meanwhile, the Department of Health and Social Care in England asked women to share their experiences with the gender health gap as part of International Women’s Day.

But one topic that still isn’t being discussed much is the health risks women face because of the lack of gender diversity among regulators who approve clinical trials. In my 25 years in research and development and now as COO of Health Decisions, a Durham, N.C.-based full-service contract research organization involved in developing drugs and medical devices for women’s health, I’ve seen this firsthand. In speaking to regulatory bodies around the world, I seldom see any women on the panels that decide which drug and device trials get prioritized. That means people who are not directly affected by these conditions are calling the shots—and often in favor of conditions of which they have more direct knowledge.

This sets the stage for unconscious bias—and it is amplifying disparities that already exist in research funding. One recent study in the Journal of Women’s Health found that the National Institutes of Health apply “a disproportionate share of its resources to diseases that primarily affect men, at the expense of those that primarily affect women.”

In nearly three-quarters of cases where a disease primarily affects one gender, funding patterns favor males, the researcher found. Either diseases that affect more women—such as migraines, multiple sclerosis and rheumatoid arthritis—were underfunded, or diseases that affect more men, such as HIV/AIDs, tuberculosis and hepatitis, were overfunded. All told, 14 diseases that affect more women than men were among the underfunded, while just one that affects men more (liver cancer) was underfunded.

Slow-tracking solutions that can save women’s lives has tragic consequences for families all over the world. While COVID vaccines were being approved within months—a welcome advance—millions of women were dying from cervical, ovarian and uterine cancer because of critical gaps in diagnostics and treatment.

Now that we know we can introduce diagnostics and treatment at warp speed for COVID, we need to speed up the pipeline of approvals for diagnostics and treatments that disproportionately affect women. Given that it often takes 12 years for many medical innovations to come to market, and there is often a shortage of women to participate in clinical trials, there is no time to waste in addressing this inequity.

Political leaders can only do so much to address gender imbalances among regulators. The regulatory community needs to take a close look at its commitment to diversity, inclusion and equity and take concrete steps to make sure that the decision-makers on both medical-device and drug trials include equal representation of women. In the United States, a good place to start is at critical agencies such as the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

These agencies have the power to bring life-saving tests and treatments to market. It’s time for them to put systems in place that ensure that these treatments benefit all people, including women, and that long-overdue solutions for women can move ahead more quickly. Giving more women a seat at the table will make this more likely to happen.

Mary Gunn is COO of Health Decisions, a full-service contract research organization involved in developing drugs and medical devices for women’s health, and a member of YPO.