By Joy S. Braun, Vice President of Strategic Initiatives & Partnerships.
The recently released National Academies of Sciences, Engineering, and Medicine report Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups outlines the high cost of health care and poor patient outcomes for large numbers of underrepresented and diverse populations in research and clinical trials across America.
As the report notes, for over three decades the Society for Women’s Health Research (SWHR) has been a leader in advocating for increased diversity within clinical trials. SWHR continues to prioritize its efforts to ensure that diverse populations of women, pregnant and lactating women, and underrepresented minority populations are actively recruited and retained in clinical trials to improve research outcomes and extend the length and quality of life for all patients across the lifespan.
In 2011, SWHR published Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials, which identified opportunities such as community engagement, trust building, recruitment of diverse health care providers, and disease education for patients and clinicians as a means to diversify populations in clinical trials.
Although there has been some progress since 2011, much more needs to be done to ensure research represents the populations affected, and considers the changing demographics of the United States.
Among the populations often underrepresented in research are women who are pregnant, of reproductive age, or lactating; racial and ethnic populations; older adults; LGBTQIA+ communities; individuals with disabilities; and people with chronic health conditions. Populations living in rural America or who live farther from care sites must also be included. Not regularly including these underrepresented populations in research can contribute to health inequities and limit the safety and effectiveness of therapeutics and devices.
SWHR recently launched the Women’s Health Equity Initiative to highlight statistics on women’s health in the United States and engage communities on solutions to improve health equity across multiple disease states, conditions, and life stages. Women experience health disparities throughout their lifespans because of their gender, historic health inequities in the health care system, and socioeconomic conditions. For example, 16% of women report fair or poor health status, according to the Centers for Disease Control and Prevention (CDC)’s Behavioral Risk Factor Surveillance System (BRFSS). These percentages are even higher among women of color: 23% of Native American women, 22% of Hispanic women, 20% of Black women, 14% of white women, and 8% of Asian American women.
Health disparities are particularly present in maternal health. SWHR continues to lead efforts to improve maternal health outcomes and advance health equity for mothers by pushing for the increased inclusion of pregnant and lactating women in clinical trials. Most recently, SWHR assumed the administration of the Coalition to Advance Maternal Therapeutics, a coalition of maternal health stakeholders seeking better understanding of the safety and efficacy of prescription drugs, therapeutics, and vaccines used during pregnancy and breastfeeding. Each year, nearly 4 million women in the United States give birth and more than 3 million breastfeed their infants — and nearly all of these women will take a medication or receive a vaccine. Yet, not enough is known about the effect of most drugs on a woman and her pregnancy, or the ways in which pregnancy may alter the uptake, metabolism, and effect of medication. Without reliable data, women who are pregnant or nursing may decide to stop taking necessary medications, increasing health risks for both mother and child.
The National Academies report supports industry incentives, such as tax credits, fast-track eligibility, exemption from some Food and Drug Administration (FDA) application fees, and extended market exclusivity for drugs. It also recommends removing current barriers, such as remuneration for lost wages, transportation costs, dependent care, and housing, for clinical trial participants Similarly, SWHR’s 2011 report recommended participant expense reimbursements as a way to diversify clinical trials and remove barriers to participation.
Industry member organizations are also engaging in initiatives to address the need to include diverse populations in medical research by removing barriers to participation. PhRMA recently announced a collaborative effort with three leading academic health centers to build trust and address systemic barriers to participation Their priorities include adding locally-based clinical trial sites in historically underserved communities, raising awareness across communities, providing resources and technical support, and offering training opportunities and mentorships for researchers and staff. AdvaMed launched a health equity initiative during the COVID-19 pandemic to promote inclusion and equity in health care and research in the medical technology industry; they also developed a membership resource, Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities, outlining considerations and approaches to help research sponsors improve inclusion of underrepresented groups in clinical research.
SWHR, in collaboration with our diverse partners and stakeholders, continues to strive and advocate for the inclusion of women and underrepresented populations in research and clinical trials, with the knowledge that such inclusion will provide meaningful data to both advance innovation and improve patient outcomes for all populations.