Minority underrepresentation in clinical trials can adversely affect patient outcomes in minority populations and further increase racial disparities.
Racial disparities in clinical trials adversely affect patient outcomes in minority populations. Although historically, Black populations have been used as unconsenting research participants in studies such as the Tuskegee Syphilis Experiment which began in 1932, or the use of Henrietta Lacks’ cervical cancer cells beginning in 1951, consenting minority research participants are often absent from important research. Minority participation in diabetes drug trials may help lower minority morbidity rates.
A study published in Clinical Diabetes sought to find and detail all clinical drug trials for type 2 diabetes that included Asian, African American, or Hispanic participants1. Although Asians, Blacks, and Hispanics all have a higher prevalence of type 2 diabetes than Whites in the United States, the study found that only four drugs/drug classes were tested in all three of these populations. There were nineteen individual drugs, and one drug class was tested in Asians, African Americans, or Hispanics. There were five medications that were tested in two out of three of these minority populations2.
A research article published in the journal Diabetes Care surveyed clinical studies for diabetic medical devices, such as insulin pumps and continuous glucose monitors. Evidence shows that Black and Hispanics use these devices significantly less than white populations. This study found that the enrollment of racial/ethnic minority groups was not proportionately representative of the estimated minority with type 1 diabetes. None of the trials specified minority groups as a recruitment target, even though the U.S. Food and Drug Administration (FDA) recommends the inclusion of minorities in clinical trials. Some trials were pivotal in gaining FDA approval for device use despite being trialed without appropriate representation of affected groups2.
Minority underrepresentation in clinical trials works to further increase racial disparity by possibly decreasing the effectiveness of drugs and devices needed for diabetic management. The first step is to advocate for and conduct clinical trials that fully encompass the most affected populations. Actionable steps include increased recruitment of minorities in clinical trials by increasing patient confidence in medical research and providing education regarding the importance of participation.
References
Rodríguez, J. E., & Campbell, K. M. (2017). Racial and Ethnic Disparities in Prevalence and Care of Patients With Type 2 Diabetes. Clinical Diabetes, 35(1), 66-70. doi:10.2337/cd15-0048
Akturk, H. K., Agarwal, S., Hoffecker, L., & Shah, V. N. (2021). Inequity in Racial-Ethnic Representation in Randomized Controlled Trials of Diabetes Technologies in Type 1 Diabetes: Critical Need for New Standards. Diabetes Care, 44(6), e121-e123. doi:10.2337/dc20-3063
