Editor: What To Know
- Co study found that 70% of potential participants in clinical trials live further than two hours away from trial sites, and another survey found that 1 in 4 potential candidates declined to participate in clinical trials due to excessive distance.
- The Food and Drug Administration (FDA) is already taking necessary steps to close gender and racial gaps in clinical research with a new 2023 omnibus spending bill that requires a diversity action plan in trials.
- At one time, women of childbearing age were excluded by federal policy from participation in clinical trials primarily due to fear of thalidomide-like effects on a developing fetus.
By: Kelly Snow
Chief of Staff, Suvoda
From lifesaving anti-malaria therapeutics to advancing cancer research with discoveries on cellular aging, women’s contributions have been instrumental to advancing science. Yet, women remain stubbornly underrepresented in one key area of research: clinical trial participation.
A review of federal data on 1,433 clinical trials reveals that only 41.2% of participants were female despite making up 50.5% of the U.S. population. Since women can react differently than men to treatments, their underrepresentation in studies – and especially the underrepresentation of women of color – may have severe implications for widening health disparities.
The Food and Drug Administration (FDA) is already taking necessary steps to close gender and racial gaps in clinical research with a new 2023 omnibus spending bill that requires a diversity action plan in trials. It is a promising start, as a more representative patient population in clinical trials is essential for developing medicines to serve those who need them most.
Since March is Women’s History Month, I’d like to explore how the industry can encourage female participation in clinical trials to advance the discovery of lifesaving therapeutics. While this effort may feel daunting, it is both possible and necessary.
Underrepresentation in research
At one time, women of childbearing age were excluded by federal policy from participation in clinical trials primarily due to fear of thalidomide-like effects on a developing fetus. However, participation remained low even after the rule was rescinded in 1993, and women have been chronically underrepresented in clinical research ever since. This is further compounded by women’s family and childcare responsibilities, financial barriers to study participation, and difficulty accessing study sites. As an example of these access challenges, one McKinsey & Co study found that 70% of potential participants in clinical trials live further than two hours away from trial sites, and another survey found that 1 in 4 potential candidates declined to participate in clinical trials due to excessive distance.
The gender gap in clinical trial participation is seen across multiple therapeutic areas. For example, among the 662 published neuro-oncology trials from 2000 to 2019, only 37.5% of the participants were women. Overall, 51% of cancer patients are women, although only 41% of cancer trial participants are female. A review of enrollment in heart failure clinical trials also shows that female participation remained stagnant at 20–30% over the past four decades.
When examining clinical trial participation among women by race and ethnicity, we see women of color are even less likely to participate. In 2021 alone, two novel therapies were approved by the FDA to treat endometrial cancer and metastatic cervical cancer, yet the majority of participants in those studies were white females. This is particularly concerning, considering black women have twice the mortality rate for endometrial cancer compared to white women.
Why diversity in clinical trials matters
Diversity in clinical trials leads to more representative study data that helps researchers better understand the impact of gender and racial differences in drug responses. Therapies designed for the specific needs of varied communities can contribute to reducing health disparities and ultimately, to saving lives.
For instance, a retrospective study that included data from a large and diverse group of lung cancer patients revealed the positive impact of Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy on Asian females. It was shown to have a 26% reduction in premature death for Asian females but only about 16% for non-Asian males.
Effective clinical trial representation is also important for adequate patient enrollment. For example, a Global Data survey found that as many as 25% of rare disease trials fail due to insufficient enrollment. Thoughtfully recruiting a diverse group of patients can help ensure a larger study population with better patient demographic representation. By doing so, we can contribute to clinical data that reflects a more accurate picture of who could benefit from the studied intervention and give trials a better chance to avoid premature study termination.
Increasing diversity with practical solutions
Leadership is needed throughout all stages of research and development to ensure diversity in trial selection and patient recruitment if we are to serve the groups most impacted by disease effectively. The FDA has highlighted the important role of academia and the biopharmaceutical industry in advancing clinical trial diversity through modifications to protocol design, eligibility criteria, and study enrollment practices—especially in making trial participation less burdensome for patients.
Employing digital tools and technology platforms that help decentralize aspects of clinical trials may help bridge the divide between patient and trial sites, making trial participation easier for patients and opening study sponsors’ access to a broader pool of potential candidates for greater diversity in their trials. Digital technologies can make it easier for patients to provide consent, submit accurate data, and receive direct delivery of study therapeutics remotely. For example, eConsent and eCOA can enable easier access to studies, contributing to greater inclusion of remote patient populations and those from communities traditionally marginalized in the healthcare system. They also hold the promise of facilitating increased diversity in clinical trials by curbing unconscious bias on the part of investigators when selecting trial participants or on the part of participants when evaluating whether to join a study.
Of course, technology isn’t the only answer. We need commitment among institutions and organizations involved in clinical research to diversify participant populations. This means proactive, practical strategies to build trust among underrepresented communities, beginning with developing a diverse pool of investigators and staff and establishing networks within these communities.
With effort, practical solutions, and leadership, I am optimistic we can improve representation in clinical trials, to increase access to and effectiveness of life–saving medications.
