The importance of diversity in clinical trials

A troubling gap exists between cancer treatment and cancer outcomes based on race, ethnicity, socioeconomic status, sexual orientation, and other characteristics.

Particularly notable statistics include (1):

• 111% higher risk of death from prostate cancer for African American individuals than white individuals
• 39% higher likelihood of death from breast cancer for African American women than white women
• Double the likelihood of death from stomach cancer for Asian/Pacific Islander adults than white adults
• Double the likelihood of liver and bile duct cancer for Native Americans and native Alaskans than white individuals

While certain statistics may reflect progress—e.g., the cancer death rate for African American individuals was 33% higher than for white individuals in 1990 but 16% higher in 2016—a huge discrepancy persists. The contributing factors to cancer are complex, such as genetics, differences in access to quality care, and a lack of medical research across diverse study subjects. By embracing diversity in clinical trials, however, researchers can obtain information that may vitally inform precision medicine to achieve health equity across populations. (2)

Genes matter in cancer

Physical, environmental, and genetic factors, including race and ethnicity, can all affect different populations’ risks for developing certain diseases, including cancer. (3)

Numerous studies report ancestry-related differences in prostate cancers and breast cancers from African American and white individuals at the DNA, RNA, and protein levels. Ancestry-related genetic differences have also been linked to African American, Hispanic, and white individuals’ different risks for developing breast cancer. (2)

Genetics can influence or determine how people will respond to a treatment, and only diversity in clinical trials can unearth these critical disparities. For example, a clinical trial showed that naltrexone was an effective substance abuse treatment for white populations but not for African American populations. Without significant African American representation in the trial, the researchers would have missed this information, leading future patients to possibly receive a harmful or ineffective medication. (1)

Inability to access high-quality care

While some cancers are curable if caught early, certain social determinants of health, including geographical location, and socioeconomic status inhibit access to high-quality care and disease prognosis. Because of existing systemic inequities that disproportionately impact people of color, these populations are more often uninsured, underinsured, or live in an area without access to nearby primary or specialty care.

Moreover, historical malpractice in the medical and research industries fosters mistrust in healthcare among certain populations. For example, experiments that harmed specific communities – including the Tuskegee Syphilis Study that deliberately withheld treatment from Black, male participants with syphilis in order to monitor their decline in health over the course of 40 years; and forced or coerced sterilization of Native American women in the 1970s – make these populations appropriately apprehensive about clinical studies and medicine in general. (4) Because of this mistrust, they are less likely to seek out opportunities to participate in research.

The call for more diversity in clinical trials

Until 1993, women and ethnic minorities were not required to be included in research studies. (5) While codifying the need for participants from diverse backgrounds was a good starting point, approaching clinical research with a goal of health equity will help ensure all patients with a cancer diagnosis benefit from clinical breakthroughs and innovations, especially those most impacted by the disease being studied. Racial minority enrollment in clinical trials has a direct impact on survivorship in these populations, and continuous efforts to increase diversity in studies will, in turn, lead to greater access to specialty care for high-risk populations. (4)

Looking ahead

Research is driving tremendous progress against cancer, but the challenge to reach everyone equally with these advances remains. (2) By prioritizing diverse representation in clinical trials, researchers can gain crucial information to inform precision medicine approaches to cancer care.

To fairly represent underserved populations, the healthcare industry must also prioritize extending access to leading expertise that levels disparities in cancer care. Employers can help—by enabling access to quality cancer support for their employees and family members to help optimize outcomes, regardless of their job level and ZIP code.

To learn how you can better support your employees and their families with cancer,?contact us.

References

1?City of Hope. City of Hope scientists tackle issue of diversity in research, clinical trials. https://www.cityofhope.org/breakthroughs/city-of-scientists-tackle-diversity-in-research-clinical-trials. Published June 18, 2021. Accessed October 10, 2022.

2?American Association for Cancer Research. AACR cancer disparities progress report 2022. https://cancerprogressreport.aacr.org/disparities/. Published 2022. Accessed October 11, 2022.

3 Centers for Disease Control. Populations and vulnerabilities. https://www.cdc.gov/nceh/tracking/topics/PopulationsVulnerabilities.htm. Accessed October 11, 2022. ?

4 Woods-Burnham L, Johnson JR, Hooker SE, Bedell FW, Dorff TB, Kittles RA. The role of diverse populations in US clinical trials.?Med,?2021;2(1), 21-24.

5 National Institute of Health. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. https://grants.nih.gov/policy/inclusion/women-and-minorities.htm. Accessed October 11, 2022.