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September 19, 2022 01:01 AM

Insufficient diversity in clinical trials is holding us back

Rep. Robin Kelly
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    Rep. Robin Kelly (D-Illinois)

    As we work to address problems within our healthcare system and improve patient outcomes, we cannot overlook the urgent need to increase clinical trial diversity. We are missing out on opportunities to decrease inequities and the chance to improve health science overall.

    According to Food and Drug Administration data for 2020, 75% of drug trial participants were white, 11% were Hispanic, 8% were Black, and 6% were Asian. That is an unacceptable representation of our population, and reflects an urgent need to make clinical trials more accessible and attractive to communities of color.

    Communities of color are often understandably skeptical of clinical trials. Studies like the Tuskegee syphilis experiment and decades of forced sterilization of African Americans and Latino Americans have created lasting fear and trepidation around medical trials. We still have work to do to establish trust in those communities. That’s why I have advocated for investments in public awareness and community outreach to clearly explain the importance and benefits of clinical trial participation.

    The lack of sufficient diversity is harming patient outcomes. For example, even though the Prostate Cancer Foundation reports that Black men are 75% more likely to develop prostate cancer and are much more likely to die of it, the median percentage of Blacks in prostate cancer clinical trials funded by the National Institutes of Health in fiscal 2018 was only 8%. Similarly, even though Hispanic adults are 70% more likely than non-Hispanic white adults to be diagnosed with diabetes, the median percentage of clinical trial participants was just 6%.

    REP. ROBIN KELLY (D-ILLINOIS)

    SERVING SINCE: 2013, now in her fifth term.

    HEALTHCARE-RELATED COMMITTEES: Energy and Commerce, serving as vice chair. She is also a member of its Health Subcommittee.

    Racial diversity is not the only category we need to improve. We must also diversify clinical trials with people across age groups and by sex and ethnicity. Last year, in an analysis of more than 20,000 trials over the past 20 years, the NIH found that sex bias persists within clinical trials, with male and female participants underrepresented in different areas of research. It’s essential that we follow the data to ensure that our clinical trials adequately represent everyone who may be impacted by a treatment or disease.

    Moreover, participants in research on public health issues do not always reflect the people most impacted by the issue. For example, even though men are 3.7 times more likely to die by suicide than women, the male median percentage rate of participation in research studies on suicide prevention was only 29%.

    These low rates of representative participant samples are concerning because people may react differently to certain interventions, drugs and products based on their race, ethnicity, age or sex. That is why I have introduced the NIH Clinical Trial Diversity Act. We cannot rectify America’s health inequities without studying the treatments within the populations that would actually use the drugs.

    This bipartisan legislation builds on NIH policies to enhance the inclusion of women, racially and ethnically diverse individuals and people across the lifespan in all NIH-funded trials. The bill requires the agency to work with clinical trial sponsors to develop clear and measurable recruitment and retention goals based on disease/condition prevalence. It also calls for improved recruitment plans; less burdensome follow-ups to make it easier for people to complete participation; and a public awareness campaign across federal agencies related to research participation opportunities.

    Private industry and health advocates are supportive of increasing clinical trial diversity. In developing the NIH Clinical Trial Diversity Act, I worked with and received endorsements for the bill from a broad group of nationally and internationally respected healthcare organizations.

    Both healthcare advocates and private industry representatives recognize the value in expanding clinical trials to improve diagnoses and treatment options. Undeniably, we know America has a health equity problem. Increasing clinical trial diversity is a good start to help us solve that problem.

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