Better Science, Better Medicine: How Clinical Research Advances Women’s Health

Every International Women’s Day invites reflection: Where have we made strides toward equity, and where do critical gaps remain? In clinical research, we see clear and sometimes sobering examples of how important these reflections can be. Until 1993, women weren’t even required to be included in U.S. clinical trials — an eye-opening fact that illustrates how recently the pursuit of truly representative research began. 

And while progress has been made, the work is far from finished. Trials that fail to reflect the spectrum of patients likely to need the treatment — across gender, race, and otherwise — risk producing therapies that work well for some but fall short for others. 

A recent JAMA study highlighted this challenge, revealing that women account for only about one-third (29%) of participants in cardiovascular device clinical trials. This historical trend isn’t relegated strictly to medical devices, either. Similar challenges persist in biopharmaceutical research at large, creating blind spots in the understanding of treatment safety and efficacy across sexes and other demographic groups.

What makes representation so impactful is its dual role: it elevates the quality of research while ensuring healthcare works better for everyone. Simply put, better representation leads to better science, which leads to better medicine.

Collaboration as a catalyst for change

The most groundbreaking discoveries come from combining different ways of thinking about nuanced problems. Across the industry, many companies have long recognized the challenges of trial representation and taken proactive steps to address them within their own organizations. These efforts have been instrumental in moving the needle. 

At the same time, no single organization can untangle the complexities of trial representation alone. True progress requires sponsors, trial sites, regulators and patients working together to break down those walls and reimagine what clinical trials can be.

The good news: momentum is building. Across the biopharmaceutical ecosystem, companies are leaning into collaboration, driving real solutions. One persistent challenge — making sure both sponsors and trial sites are equipped to advance trial representation — is being tackled head-on. Sponsors are reshaping protocols with things like more inclusive eligibility criteria and strategic site selection, while sites are building their capacity to engage patient populations with broader demographics. By sharing expertise and resources, organizations have built tools that help identify and remove roadblocks at every level, creating research environments that are more inclusive from day one.

Tools supporting inclusive and patient-centered research

Turning ambition into reality requires practical resources that enable sites and sponsors to meet patients where they are, embed their voices into trial design, and reduce participation barriers. We are seeing leading biopharma companies collectively tackle these industry-wide issues. Through their collective work, free tools and resources are available for biopharma companies — whether large or small – to utilize in their own clinical trials.  The simple truth is that shared solutions to common challenges in clinical research can lead to better science and better medicine.

One challenge in particular is being able to successfully include patients’ different perspectives, backgrounds, and feedback into the conversation from the start of the trial. By doing so, researchers can account for real-world challenges — work schedules, caregiving duties, transportation — and identify solutions that would make participation more accessible for all, particularly in this case — women. And with continuous feedback loops in place, researchers can catch and address obstacles more rapidly, refining future studies to be more inclusive and effective. 

To strengthen this process, initiative groups encourage trial sponsors to leverage tools that can collect timely insights from participants. By listening to patient perspectives throughout a study, researchers can fine-tune trial designs and remove hidden hindrances that might otherwise limit participation among specific demographic groups.

The push for greater representation is further emphasized by biopharma leaders through actionable guidance for sites and sponsors to improve trial accessibility. These practical strategies can help pave the way for trials that reflect the real world, inviting diversity and ensuring every voice contributes to better science.

Maternal health research is also making strides. Teams of experts have come together to identify and tackle critical gaps in medicine safety data, giving pregnant and breastfeeding women a voice in the research conversation. One output is a comprehensive evaluation of regulations across 19 countries, which also identifies health authority, academic institution and industry consortium efforts to address the issue. This collaborative approach is intended to enhance both the quality of safety data and patient participation in research, ultimately providing healthcare providers with more robust evidence for treatment decisions.

The path forward

The clinical research ecosystem is shifting toward trials that fit into patients’ lives, not the other way around. Modern trial designs, digital solutions and a deeper understanding of patient realities are helping to open research to more people, including women and others who have historically been underrepresented.

But progress is not self-sustaining. Momentum must be fed. As medicine advances and patient needs evolve, so too must the methods we rely on to test and deliver new treatments. The commitment to this evolution through ecosystem-wide collaboration will push clinical research forward.

Because better trials lead to better science. And better science leads to better health — for every patient, everywhere.

Photo: FotografiaBasica, Getty Images

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