Closing The Gender Gap In Clinical Trials With Digital Devices
This article was originally published in Clinical Leader on August 15, 2025.
For decades, women have been underrepresented in clinical trials — a gap that’s not just unfortunate but dangerous. When research isn’t representative of half the global population, we can’t truly develop treatments that are safe and effective for all.
It’s not that researchers don’t want women in their studies. Many trial designs fail to account for real-life barriers such as rigid work schedules, caregiving responsibilities, and the time commitment involved. For many women, especially those in underserved communities, these hurdles are simply too high.
Digital health and decentralized trials are making research more flexible, inclusive, and human, moving beyond one-size-fits-all approaches.
Meeting Women Where They Are
Traditional study models often ignore the real-life challenges women face in balancing research participation with daily life. Globally, the World Health Organization (WHO) estimates that 76% of caregivers are women. They are caring for children, aging parents, and sometimes even both, while maintaining full-time work. The expectation that women can carve out time for clinic visits during the workday just isn’t realistic.
Some researchers now offer transport and caregiving support, flexible scheduling, and at-home services via mobile nurses. For many women, this degree of inclusivity is vital to their participation.
Even with these adjustments, is it enough? What more can be done to boost inclusivity for women in clinical research?
Digital Tools As Equalizers
Digital health technologies play a pivotal role in leveling the playing field. Remote monitoring, mobile health apps, and wearable devices are removing the need for in-person visits while still collecting high-quality, meaningful data.
For example, one FDA-cleared fertility tracking bracelet has been used in clinical trials to monitor physiological changes across the menstrual cycle, capturing subtle patterns that might be missed through traditional observation methods. Likewise, a wearable ring for sleep and activity tracking has been incorporated into studies exploring the impact of hormonal changes on mood and sleep throughout the menstrual cycle.
Mobile apps are helping to support real-time symptom monitoring, such as the PatientSpot app (formerly Arthritis Power), which enables trial participants with rheumatoid arthritis (an autoimmune condition disproportionately affecting women) to log symptoms in real time and contribute to ongoing observational research. Similarly, the Caria app has been integrated into research efforts focused on menopause, which helps women track symptoms over time, providing a window into midlife experiences that have often been underrepresented in clinical trials.
Diagnostics At Home Provide Screening Access For All
At-home diagnostic tools are gaining attention for their potential to reduce barriers to cervical cancer screening. One example is a self-collection tampon that enables at-home testing for human papillomavirus (HPV), a key risk factor for cervical cancer. While it does not replace comprehensive screening, it serves as an effective surrogate marker that can trigger further investigation when HPV is detected.
By reducing the need for invasive procedures and in-person appointments, home-based options may increase participation among women who are housebound, live in rural areas, or prefer more private, self-directed care.
Cultural Relevance And Accessibility Matter, Too
Inclusivity doesn’t stop at making trials more convenient — it also means addressing cultural, linguistic, and accessibility barriers that have long gone unaddressed. Some digital platforms like Ada Health’s symptom checker offer language options and culturally responsive interfaces to better reflect how women around the world experience and report symptoms.
Meanwhile, tools that support accessibility for women with disabilities are expanding what’s possible. Tools like Microsoft's Seeing AI voice-activated medication dispensers, which read medical labels, and the Be My Eyes app, which connects visually impaired users with volunteers for real-time help, all enable research participation for women that might have been impossible just a few years ago, in addition to supporting day-to-day health engagement.
What’s Next: AI, Personalization, And Hormone Awareness
The impact of these innovations isn’t theoretical — it’s real and measurable. Apple’s Women’s Health Study enrolled over 50,000 participants remotely, demonstrating what’s possible when research design removes traditional barriers to entry.
Looking ahead, AI and personalization will likely define the next era of women’s health research. AI-based tools are already being used to analyze health forums and online communities to help researchers identify and reach underrepresented groups of women who may not be reached through conventional recruitment methods.
One particularly promising area is real-time hormone monitoring. A simple wearable device capable of tracking hormone fluctuations continuously — much like a continuous glucose monitor (CGM) for the menstrual cycle — could completely change how we study fertility, menopause, mood disorders, and other hormone-related conditions. With continuous data, researchers could follow women’s responses to interventions throughout different life stages, not just within a narrow study window.
The Bottom Line
The gender gap in clinical trials is not just oversight but a public health failure with potential consequences to half of the global population.
Digital health technologies are fostering health equity by removing traditional barriers and offering innovative solutions that have historically excluded women from participating in research. This can’t be about checking a box for inclusion; it should be about redesigning the research ecosystem from the ground up to make room for every voice, experience, and outcome.
As these tools evolve, we can transform clinical research participation from privilege into the norm. Digital tools will improve inclusivity, but it's how quickly we can scale these solutions to ensure that every woman has the opportunity to contribute to medical progress that will make the difference.
