As key drivers of advancements in medicine, clinical trials also offer participants access to potentially cutting-edge treatments for their chronic and acute health conditions. However, despite minorities making up nearly 40% of the US population, the U.S. Food and Drug Administration (FDA) reported that roughly 75% of trial participants for drugs approved by the FDA in 2020 were white. As the doctors who diagnose disease and recommend the best course of treatment, pathologists have a vested interest in clinical trials. This article highlights the efforts of the CAP to promote and advance diversity in this critical area of medicine.
In May 2022, the CAP joined 88 other organizations in sending a community letter to two key Congressional committees—the Committee on Energy and Commerce and the Committee on Health, Education, Labor & Pensions—beseeching members of both committees to take action to increase diversity in clinical trials.
The CAP and other organizations noted “the majority of clinical trials fail overwhelmingly to achieve diverse enrollment—despite the fact that many serious and chronic diseases disproportionately impact underrepresented racial and ethnic minority groups.” This failure to ensure adequate diversity among participants inhibits full understanding of a new treatment’s safety and efficacy across populations while exacerbating disparities in access to the latest treatments, especially in cases where a new treatment might be a patient’s best—or only—option.
The signing organizations, including the CAP, requested Congressional support for the following reforms:
- Promote sponsor accountability for enrollment diversity
- Reduce travel burdens for trial participants
- Improve outreach to underserved patients and providers
- Minimize financial barriers when travel for a trial is necessary
Thanks in part to the efforts of these organizations, a 2023 funding bill passed by Congress included provisions to promote diversity in clinical trials.
In addition to co-signing the letter to Congress, the CAP approved a new public policy on clinical trial diversity in November 2022. The policy emphasizes the importance of clinical trials to pathologists, whose role is integral to guiding appropriate treatment decisions and improving patient health outcomes by evaluating and determining the effects of targeted therapies on diverse populations.
When a clinical trial population is not representative of the patient population, the resulting clinical data and conclusions may not apply to all patients undergoing that treatment. This could result in a drug or medical device being less beneficial—or even unsuitable—in practice for some patient subgroups, leading to poorer health outcomes.
To diversify clinical trials, the CAP:
- Encourages the FDA, pharmaceutical and industry partners, and health care providers to evaluate and develop eligibility criteria in clinical trials to address barriers to participation.
- Supports FDA action to issue guidance on decentralized clinical trials to promote meaningful diversity in patient engagement, enrollment, and participation in clinical trials, which may include the utilization of digital technologies or telemedicine to lessen barriers to access.
- Encourages the Department of Health and Human Services (HHS), and other agencies as appropriate, to bolster health care provider education to address barriers to diversity and inclusion in clinical trials through medical undergraduate, graduate programs, and continuing medical education programs.
- Requests that Congress authorize appropriate funding and resources to equip and inform community organizations, patient advocacy groups, health care providers, and community cancer centers to raise public awareness of clinical trials.
- Recommends the HHS and the FDA study and evaluate digital health technology and other remote methods to support diversity and access in clinical trials.
The CAP’s policy recommendations strongly echo those laid out in the community letter to urge federal action to improve the diversity of clinical trials in the United States. As minority groups continue to grow and make up a larger share of the US population, the clinical trial system must adequately represent that population to ensure participants have equitable access to leading-edge, safe treatments.
The CAP and its members strongly recognize and support the need for diversity in clinical trials to reduce disparities in health care and improve health outcomes.