Improving Health Equity for Diverse Populations in Clinical Trials

This publication was approved and written in close collaboration with Dr. Leanne Woods-Burnham.

Dr. Leanne Woods-Burnham is an Assistant Research Professor in the Department of Population Sciences Division of Health Equities in the Laboratory of Dr. Rick Kittles. Dr. Woods-Burnham is a featured expert in our health equity-focused Pro Hub that lists inclusive global healthcare professionals committed to advancing inclusive research and providing the highest quality care to all patients.

These articles are written by Diverse Health Hub to summarize complex medical research in order to facilitate deeper understanding. Diverse Health Hub publications are not intended to persuade its readers. We present information to create in-depth conversations that encourage patients to critically think and decide for themselves.

Clinical trials are a vital component of research for cancer treatments and other medical conditions. We connected with Dr. Leanne Woods-Burnham about a recent commentary on the role of diverse populations in U.S. clinical trials. 

As the population demographics of the United States continue to change, there is an even greater need for underrepresented groups to increase participation in clinical trials. For clinical trials to test and discover the most targeted and effective treatments, all genders, ethnicities, and races need adequate representation.

Barriers to Scientific Progress in Clinical Trials

The largest demographic participating in clinical trials is non-Hispanic white men. But when it comes to examining treatments for cancer and other conditions, information is especially lacking about genetic variation for Black, Indigenous, and People of Color (BIPOC) groups. This lack of information then delays advances for specific groups and can even put patients in these groups at more risk from treatments if they are not participating in clinical trials. Even in cases where some specific BIPOC races/ethnicities are impacted by a health condition or cancer at higher percentage, these same races or ethnicities are still underrepresented.

Results of Precision Clinical Trials 

Targeted therapies are especially important as treatment options for various cancer types. However, clinical trials need adequate study data on all racial or ethnic groups to decipher which targeted treatments are optimal for specific genetic factors. A past study of epidermal growth factor receptor (EGFR) in Asian patients with lung cancer serves as a prime example that yielded very positive results.

Unfortunately, the anticoagulant drug warfarin later showed a greater rate of adverse events in Hispanic and Black patients after the drug’s approval. The clinical trials of warfarin had a study group of 80 percent European ancestry and so lacked adequate data about some groups, which could have prevented complications including bleeding, blood clots, hospitalization, and death.

Some conditions that especially need more clinical trial participation by BIPOC groups are multiple myeloma and prostate cancer. If more Black patients participate in clinical trials for these conditions, then late-stage diagnosis and death rates will start to show improvements.

History of Medical Mistrust in the U.S.

After medical ethics violations in the cases of Henrietta Lacks, Tuskegee Syphilis study, and illegal sterilization of Native American women; some BIPOC patients continue to mistrust medical researchers due to these past incidents paired along with continued health disparities. Breast cancer, multiple myeloma, and prostate cancer all show disparities in health outcomes. Black Americans are known to have less aggressive myeloma, which should have better outcomes, but that is not the case. In looking at breast cancer, young Black and Latina women living in low socioeconomic status areas have a higher occurrence of more aggressive breast tumors linked to lower survival rates. And in prostate cancer, Black men have the highest prostate cancer death rate, which is 2.2 times higher than the rate for non-Latino white men. With these disparities along with a relatively short period of history as a nation, it could take decades or even generations longer to move past this mistrust of medical professionals.

Solutions Toward Clinical Trial Equity

There are several solutions to work toward greater clinical trial equity in the U.S. Many patients report feeling more comfortable with healthcare professionals who look like them. Enrollment and training of more BIPOC students in medical schools and universities serves as one solution toward equity. All of those involved in the administration of clinical trials also must work to ensure that recruitment requirements for BIPOC patients are met in clinical trials. Awareness about clinical trials must be increased by healthcare professionals and advocacy groups. And finally, access to clinical trials must be not only maintained but increased through continued use of methods like telemedicine and barber shops as access points – and coverage of travel costs and missed work should also be covered as part of clinical trial participation. Strategic and concerted efforts with these solutions must be made to work toward clinical trial equity and improved quality of life and survival rates for BIPOC patients.

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Source

Leanne Woods-Burnham, Jabril R. Johnson, Stanley E. Hooker, Jr., Fornati W. Bedell, Tanya B. Dorff, and Rick A. Kittles. The Role of Diverse Populations in US Clinical Trials. (2021) Med. https://www.cell.com/med/pdf/S2666-6340(20)30075-1.pdf