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S09: Chronically Left Out: Lack of Patient Diversity in Chronic Disease Clinical Trials in Los Angeles

Poster Presenter

Sunyoung (Stacy) Uhm

Student Researcher
USC
United States

Objectives

To evaluate the lack of diverse representation in clinical trials (CTs) conducted in Los Angeles County (LAC) studying chronic diseases, such as coronary heart disease, stroke, lung cancer, and liver disease.

Method

ClinicalTrials.gov was searched using the keywords: coronary heart disease, stroke, diabetes, liver disease, Los Angeles. Only studies with results reporting race and ethnicity were selected to compare disease-specific demographic information in patients of Los Angeles.

Results

When diabetes was studied, CTs for Type 2 had sufficient reporting of race and ethnicity as opposed to other types of diabetes, such as Type 1 and gestational. Out of the 170 Type 2 diabetes CTs, 92 trials referenced race and/or ethnicity in their study results. From these 92 trials, 56 referenced ethnicity and 86 referenced race (44 of these trials referenced both race and ethnicity). The majority of the participants from the 56 CTs that referenced ethnicity were not Hispanic/Latino where 19.74% identified as Hispanic/Latino, 57.54% as Not Hispanic/Latino, and 22.74% as unknown or not reported. Additionally, 76.94% of the participants from the 86 trials that reference race identified as White, 8.81% as Asian, 7.22% as Black/African American, 1.72% as American Indian/Alaskan Native (AI/AN), 0.24% as Native Hawaiian or Other Pacific Islander (NHOPI), 1.82% as More than One Race, 1.94% as Unknown/Not reported, and 1.30% as Other. There are 115 CTs for coronary heart disease, 70 CTs for stroke, and 194 CTs for liver diseases under the same search terms that will be further analyzed for its racial and ethnic reporting.

Conclusion

According to the LAC’s Department of Public Health, Latinos make up 49% of the county population while races, such as Black, White, Asian, AI/AN, and NHOPI make up the other half of the county, revealing a unique demographic. In LAC, the overall five leading causes of death differ from the leading causes of death for Latino/a residents; these include diabetes and liver diseases. Diabetes is a chronic disease that is a leading cause of death for Latino/a, Black, and Asian residents but not for White residents. Coronary heart disease and stroke were studied because they are prevalent chronic diseases throughout all groups. CTs for Type 2 diabetes reveal underrepresentation of minority groups among participants because the percentage of the Asian, Black/African American, AI/AN, and NHOPI groups collectively made up less than 18% of all the participants analyzed. Many of the participants (76.94%) within the CTs that referenced race identified as being White. This differs from the LAC diabetic population as 8.2% reported as being White. Hence, there is a contrast between the racial demographics of the CT participants and the diabetic population of LAC. Racial disparity within CTs for Type 2 diabetes further emphasizes the need for incentives and/or strategies to enhance diversity inclusion within CTs for Type 2 diabetes substantiating further research. While Section 907 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) called for improved inclusion of demographic subgroups, the effects of this act are not present within the Type 2 diabetes CTs conducted in Los Angeles. Overall, the results of this study imply that the CTs for diabetes within the city of Los Angeles, and perhaps LAC, lack diversity inclusion despite the diverse population of LAC. It is important to consider a diverse study population in CTs to ensure that the trial population is representative of the patients who will use the treatment and ensure results are generalizable.