Gender equity relies on health equity
Global health relies on women’s health.
As we celebrate Women’s History Month this March, the world takes a moment to recognise women’s accomplishments, while also highlighting the inequity that remains. When it comes to women’s health, those inequities are stark. And a contributing factor is the lack of women in clinical trials. When population representation falls short, medicines are less safe and effective. Measures such as the US Congress’s proposed DIVERSE Trials Act are helping drive equitable representation, but that’s just the beginning.
Dr Jecca Steinberg, a medical resident at Northwestern University Feinberg School of Medicine, explained, “Neglecting one sex in clinical trials excludes them from health innovation and skews medical evidence towards therapies, with worse efficacy in that sex.” In fact, a top reason for Food and Drug Administration (FDA) drug recall are adverse effects on women.
Gender disparity threatens not only women’s health, but also the long-term welfare of their families and communities. For the welfare of all, it’s critical to rethink clinical trial models.
Equal representation is essential for effective treatment
Diseases often present differently in women than in men – a fact that can turn fatal when physicians miss understudied warning signs in women. Further, women may process drugs differently than men and have different side effects, experiencing those side effects at higher rates and/or to a stronger degree. In fact, women experience adverse drug reactions nearly twice as often as men.
Some diseases are also more prevalent among women. However, treatments are often researched on 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.
Without equitable representation in trials, the management of care is sub-optimal, and may result in debilitating side effects and missed signals about the safety and effectiveness of therapies.
Women are still healing from a history of exclusion
The industry is working against a history of legal exclusion. 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 reaction to such tragedy is understandable, the guideline was often interpreted too broadly and excluded any woman capable of becoming pregnant.
The FDA finally lifted the restriction in 1993, but 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.
Even beyond the law, there are the pervasive injurious stereotypes. 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 patronisingly 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 rigmarole. 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.
Joan’s experience is not unique. While attitudes and legislation are changing, there’s more work to do, not just to include women in trials, but also to treat them with respect and accommodate their needs.
Parity is possible – but requires fundamental changes to access
To achieve health parity for women, we must rethink how we model clinical research – from writing decentralised clinical trial (DCT) protocols that embrace novel capabilities and community-based site locations, to encouraging (or even mandating) accommodations for women.
Consider this: a disproportionate burden of childcare and elder care falls on women, plus 75% of women between the ages 25 and 54 are employed, with about nine in 10 working full time. Few have the time or flexibility to participate in onsite trials.
This is where decentralisation is already making a significant impact. DCTs remove many of the travel and financial burdens of trial participation that plague women. In hybrid trials, women can complete enrolment or consent remotely, rather than taking time off, finding a babysitter, and driving long distances just to fill out paperwork.
Those benefits are catching on. Over the past five years, 16% of women’s health trials in the US have included some element of decentralisation. In fact, US women’s health trials have used e-diaries and other digital data collection at a higher rate compared to any other therapeutic area – placing women’s health seventh out of 22 therapeutic areas in decentralised clinical trial adoption.
For those elements of trials that must be administered onsite, simple changes can make an enormous difference. Pat Larrabee, CEO and founder of Rochester Clinical Research, 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 the Rochester 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.”
Larrabee also recognises the importance of education and awareness in drawing more women into clinical research – ensuring that they understand the importance of what’s being studied to themselves and others. “The altruism motivator is very strong in women,” added Larrabee. “We did an RSV study recently and needed young, healthy women. Everyone we contacted knew someone who'd been affected by RSV, which motivated participation, not for their own health, but for the next generation.”
Breaking into equitable treatments to break through the glass ceiling
How can women break the glass ceiling, if they are not given a fair shot at equitable healthcare? Having the right science for women directly translates to the likelihood of their lifelong success, as well as the well-being of their families and future generations.
While it feels clichéd to paint women as caretakers who put themselves last, it is nonetheless a widespread reality, whether a stay-at-home mother or a female CEO. We must do all we can to bring science, clinical trials, and the making of medicine closer to home for all women. And where we can’t meet women in their homes, we should make clinical research feel like home. From our laws to our trial design, to the amenities we provide in our clinics, it’s time to come together as an industry and a society in support of women – their health, their equity, and their success.
About the author
Sanskriti (“Sans”) Thakur is Medable’s chief growth officer and is focused on market expansion and growth initiatives to advance the company’s vision of human-centred research, enabling remote access to clinical trials, regardless of geography, income, and race. She most recently served as global life sciences research lead for Accenture, responsible for market-shaping strategy and research in therapeutics, digital health, and business model innovation. During her 18 years in the life sciences industry, Thakur has advised more than 30 companies, launched 10 products, advised digital health venture funds, and managed a leading pharmaceutical portfolio. She has authored 12 publications on various industry topics, and currently serves on the World Economic Forum global futures council for healthcare topics.