Healthy Societies Need Healthy Women; Women’s Health Relies on Equitable Clinical Research
Sanskriti Thakur
Medable
@medableinc
T

his Mother’s Day, women across the US and in other parts of the world will be celebrated, but this appreciation is not reflected in scientific research, where women continue to face stark inequities. Today’s approach, investment, and mindset fail to deliver complete healthcare to women and limit data capture. Ultimately, this severely curtails the world’s understanding of disease states that impact women the most.

In the case of representation in clinical research, women are fighting for equitable consideration. In fact, compared to men, researchers know much less about how women experience disease, which is shocking because women represent half the global population. Gaps span from healthcare diagnosing (data generation) to tracking at the national level (data collection) and translating data into insights through epidemiological studies (data analysis). These data disparities ultimately influence health outcomes for women globally by creating blind spots in the insights that drive research design, investment decisions, and pipeline priorities. Without this baseline data, pharmaceutical companies are developing medicines that are inherently less safe and effective for women. In fact, a top reason for Food and Drug Administration (FDA) drug recall is adverse effects on women. These disparities in drug development threaten not only women’s health, but also the long-term welfare of families and communities.

Progress is being made: measures such as the proposed DIVERSE Trials Act are helping to shine a light on the need for fair and equitable representation in clinical trials. However, we have a long way to go to reach equity. To protect women, mothers, families, and society at large, we must act urgently to rethink clinical research.

Inequitable Representation Produces Suboptimal Treatments

Some diseases are more prevalent among women yet are often investigated in participant pools that do not represent this real-world dynamic. A recent study found asymmetry in cardiovascular disease research between men and women: 49% of people with cardiovascular disease are women, yet only 41.9% of participants in cardiovascular research are female. Additionally, heart disease is underdiagnosed in women, despite being the leading cause of death in the US.

The same study found similar research gaps for cancer: Although 51% of cancer patients are female, only 41% of cancer trial patients are female. Worse, 60% of people with psychiatric disorders are women, but just 42% of trial participants for psychiatric drugs are female.

These imbalances have real-world implications. Without equitable representation in trials, the management of care is suboptimal, and may result in debilitating side effects and missed signals about the safety and effectiveness of therapies. Women often process drugs differently than men. They can also experience different side effects than men, and experience those side effects at higher rates and/or to a stronger degree. And diseases often present differently in women than in men to begin with—which can turn fatal when those symptoms are understudied and therefore poorly understood. For example, heart disease—the leading cause of death for both men and women in the US—often develops in women a decade later than men due to protective effects of female hormones. Heart attack symptoms in women can also differ from those of men, presenting with extreme fatigue, indigestion, and chest or neck pain. Men, on the other hand, do not have those same symptoms. Another example is sexually transmitted infections, which can affect women differently in several ways, including the expression of symptoms and potential for long-term complications.

History of Legal Exclusion and Stereotyping

The industry is working against a history of legal exclusion based on motherhood itself. In response to heartbreaking birth defects associated with thalidomide, the FDA banned “women with childbearing potential” from phase I and early phase II clinical trials in 1977. While the industry should, indeed, do all it can to protect children, the guideline was often interpreted too broadly and excluded any woman capable of becoming pregnant.

The FDA finally lifted the restriction in 1993. However, the research field is still playing catch-up; in fact, it wasn’t even a requirement to collect demographic data in clinical trials until a few years ago. Considering the 10-year R&D cycle of most new therapies, medicines coming to market today still do not represent women equally—which is unfair to them, as well as their families.

Even beyond the law, women continue to face injurious stereotypes in their pursuit of medical care. Multiple sclerosis patient Joan Jordan describes her struggles: “I wasn’t diagnosed for 14 years, in part, due to gaslighting because I was a woman. Doctors patronizingly questioned my symptoms saying, ‘Did you hit your head off the door of your car?’ Or, ‘Did you pull your ponytail too tight?’”

Once she was finally diagnosed and enrolled in a clinical trial, Joan—a busy wife and mother, already exhausted from her disease—experienced even more unnecessary complications. The trial site required Joan to take a pregnancy test at the start of each visit (even though she had an IUD), which prolonged the appointment. The site administrators were likewise inconsiderate of her requests to schedule appointments more conveniently for times when her children were in school.

As the statistics cited above illustrate, Joan’s experience is not unique. While attitudes and legislation are changing, there’s more work to do, not just to include women and mothers in trials, but also to treat them with respect and accommodate their unique needs.

New Ways to Respect Women’s Biology

To achieve health parity, we must reimagine the clinical research model. To start, industry needs to better understand important and novel data points and to apply them differently. As an example, writing decentralized clinical trial (DCT) protocols that embrace novel capabilities can help by accommodating women’s schedules. The same is true for trials that offer community-based site locations that encourage (or even mandate) accommodations for women.

Few women have the time or flexibility to participate in onsite trials. A disproportionate burden of childcare and elder care falls on women, plus 75% of women between the ages of 25 and 54 are employed, with about 9 in 10 working full time. This is where transformation with digitization and decentralization is making a significant impact. Applying digital methods to research and development removes many of the travel and financial burdens of trial participation that plague women, especially working mothers. In hybrid trials, for example, women can complete enrollment or consent remotely rather than taking time off, finding a babysitter, and driving long distances just to fill out paperwork.

These solutions are gaining speed, especially in women’s health. Over the past five years, 16% of women’s health trials in the US have included some element of decentralization. US women’s health trials have also used e-diaries and other digital data collection at a higher rate compared to any other therapeutic area, placing women’s health 7th out of 22 therapeutic areas in DCT adoption .

For those elements of trials that must be administered onsite, simple changes can make an enormous difference for women and their families. Pat Larrabee, CEO and founder of a large research center in upstate New York, has begun to offer snacks and activities for children accompanying their mothers onsite and staff who provide childcare during visits. Larrabee also installed large exam rooms to accommodate entire families. As a result, more women participate in trials at Larrabee’s clinic than men.

“We do many things to make it easy,” said Larrabee. “We offer Uber Health if people can’t get to the site; you’re not going to take a bus with three kids. If you can remove the main obstacles—childcare, transportation, convenience—we can make trial participation easier for women and more likely.”

Global Health Must Include Women’s Health

From laws and funding to trial design and trial site amenities, it’s time to come together in support of equitable health for women. Whether they are stay-at-home mothers or CEOs, women are more likely to provide care for others while putting themselves last. This self-sacrifice directly diminishes their likelihood to opt into time-consuming, expensive, and inconvenient scientific research.

Ultimately, this is about better science and raising the global standards of healthcare.

The industry must understand the funding frameworks, translate that to improved drug development, and generate the right data to make better medicine for everyone. Innovative clinical trial models like decentralization are already helping science reach women where they are and for what they need. But the call to action is broader and requires a mindset shift on the importance of modernizing all systems of care.

This Mother’s Day, let’s honor all women with actions toward equitable science—which will directly improve global health for future generations.