With the ever-increasing diversity of our nation come new opportunities and challenges for healthcare providers and policymakers. Despite the many notable advancements that have been achieved in the last decade, new treatments have failed to be effectively applied to racial and ethnic minority populations due to a stark lack of minority participation in clinical trials.
Though it is federally mandated that racial minorities must be included in clinical trials and research studies, recruiting subjects from such populations has proved to be a challenge. In a recent study by Natale et al., it was concluded that parents of African American and Hispanic American children were “less likely to be approached for, and more frequently declined consent” to enter their children in clinical trials. Additionally, in a study by Paskett et al., less than 5% of participants in breast and prostate cancer prevention trials are from minority populations, despite a significantly larger incidence of prostate cancer in black men and a greater risk of breast cancer-related death in black women than in any other race. Overall, African Americans, who comprise 13.2% of the population, make up only 5% of all clinical trial participants, while Hispanics, who comprise 16% of the population, only account for a mere 1% of clinical trial participants. This underrepresentation of minority groups in clinical trials is a significant issue, as advanced medical treatments cannot safely be applied to minority patients if they are not represented in the research data.
There are many clinician and patient-centered barriers that stand in the way of minority participation in clinical trials. As noted by Fisher et al., distrust of academic institutions and clinical researchers is a major barrier among African Americans, particularly due to a long history of exploitation extending even beyond the infamous Tuskegee Syphilis Study. Additionally, many minority patients receive poor financial compensation in proportion to the demands of the study, as they are often required to take unpaid medical leave from their day-to-day jobs to attend procedures and appointments. As found by Walter et al., requested payment differs significantly among racial and ethnic groups, with non-Hispanic white subjects requesting a mean of $300 and Hispanic subjects requesting a mean of $500 in exchange for their participation in low-risk clinical trials. Ethnic minorities- Hispanics in particular- often request greater payment for their participation in clinical trials, suggesting inadequate compensation as a possible explanation for their underenrollment. Minority patients also face a language and literacy barrier when communicating with their physician, and are often unwilling to enroll in clinical trials due to an insufficient level of comfort with hospital staff. Furthermore, clinical trials tend to recruit subjects from large urban hospitals, often passing over smaller community hospitals where many minority patients seek treatment and thus overlooking a large proportion of the minority patient base.
The solution to this problem lies in providing culturally competent care. For many patients, cultural competency plays a fundamental role in their willingness to participate in medical trials. The term “cultural competency” refers to the ability of healthcare providers to “effectively deliver healthcare services that meet the social, cultural, and linguistic needs of patients.” In a study by Saha et al. that analyzed the relationship between subjects’ sociodemographic characteristics and their sources of healthcare, researchers found most notably that black and Hispanic Americans tended to seek care primarily from “physicians of their own race” due to an increased sense of cultural understanding and more effective patient-physician communication. Additionally, in a survey conducted by researchers at the University of Maryland, it was concluded that minority parents were more likely to provide informed consent when asked to participate in clinical trials by a minority physician. Altogether, patients report better relationships when treated by physicians who are responsive to diverse patient populations and are willing to accommodate cultural diversity, as evidenced by “effective communication, partnership, and trust.”
The above studies suggest that increasing the number of medical personnel who are both willing and able to communicate effectively with minority patients can help to ensure that any new treatments or strategies will be relevant to minority populations. In a recent city-wide effort, healthcare systems in New York’s Bronx and Brooklyn boroughs have already begun to develop community-based health networks and large-scale providers for the uninsured in order to better meet the needs of New York’s minority population. Aiming to provide culturally and linguistically-competent health care to all, hospitals within the Brooklyn Perinatal Network and the Bronx Health Link have integrated components of cultural competence into both their educational curriculum and workplace. This has included, but is not limited to, investing more resources in hiring multilingual staff, translating consent forms into multiple languages, and recruiting subjects from minority communities.
Such an improvement in the cultural competency of healthcare providers and policymakers nationwide may finally begin to break down the cultural barriers preventing minority participation in clinical trials. The importance of cultural understanding cannot be more underscored than in this day and age, and a proactive restructuring of current methods for obtaining patient consent is imperative if the enrollment of minorities in clinical trials is to grow in the future.
- Natale, J. E., Lebet, R., Joseph, J. G., Ulysse, C., Ascenzi, J., Wypij, D., & Curley, M. A. (2017). Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial. The Journal of pediatrics, 184, 204-208.
- Paskett, E. D., DeGraffinreid, C., Tatum, C. M., & Margitić, S. E. (1996). The recruitment of African-Americans to cancer prevention and control studies. Preventive Medicine, 25(5), 547-553.
- “Prostate Cancer.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 19 June 2017, www.cdc.gov/cancer/prostate/statistics/race.htm.
- “Breast Cancer.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 15 June 2016, www.cdc.gov/cancer/breast/statistics/race.htm.
- Bookbinder, Maxine. “The Diversity Problem: Making Clinical Trials Work for Everyone.”Clinical Informatic News, Cambridge Innovation Institute, 31 Mar. 2016, www.clinicalinformaticsnews.com/2016/3/31/diversity-problem-making-clinical-trials-work-everyone.aspx.
- Fisher JA, Kalbaugh CA. Challenging Assumptions About Minority Participation in US Clinical Research. American Journal of Public Health. 2011;101(12):2217-2222. doi:10.2105/AJPH.2011.300279.
- Walter, J. K., Burke, J. F., & Davis, M. M. (2013). Research Participation by Low‐Income and Racial/Ethnic Minority Groups: How Payment May Change the Balance. Clinical and translational science, 6(5), 363-371.
- “Cultural Competence in Health Care: Is It Important for People with Chronic Conditions?” Health Policy Institute | Georgetown University, Georgetown University, 5 Feb. 2014, hpi.georgetown.edu/agingsociety/pubhtml/cultural/cultural.html.
- Saha, S., Taggart, S. H., Komaromy, M., & Bindman, A. B. (2000). Do patients choose physicians of their own race?. Health affairs, 19(4), 76-83.
- Quinn, S. C., Garza, M. A., Butler, J., Fryer, C. S., Casper, E. T., Thomas, S. B., … Kim, K. H. (2012). Improving Informed Consent with Minority Participants: Results from Researcher and Community Surveys. Journal of Empirical Research on Human Research Ethics : JERHRE, 7(5), 44–55. http://doi.org/10.1525/jer.2012.7.5.44
- Commission on the Public’s Health System. “Culturally Competent Care: Some Examples of What Works.” CPHS, 2010, pp. 1–33.