Narine, Laura RACIAL, ETHNIC, SEX, AND AGE DISPARITIES IN CAR T-CELL CLINICAL TRIALS. 2023. Radford University, Doctoral Capstone Project. Radford University Scholars' Repository.
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Abstract
Health and healthcare disparities harm the sub-population groups who experience greater social and economic barriers to healthcare access. Historically based provider biases, patient culture and social beliefs, and healthcare system practices contribute to a continued disparity in care for many underrepresented groups based on race, ethnicity, gender, and age, with paralleled disparities in oncology treatments and clinical trial enrollment. Extrapolated data from clinical trials must contain a participant composition that reflects the disease population to generate reliable, safe, and efficacious results after treatment commercialization. Objectives: This purpose of this study was to examine nationally registered immuno-oncology clinical trials, specifically CAR T-cell studies within the ClinicalTrials.gov database, for racial/ethnic, age, and gender disparities. Methodology: The age, gender, racial, and ethnic breakdown of identified trials were compared to the US population-estimates derived from the Surveillance, Epidemiology, and End Results (SEER) Program. Analysis was performed for determining the mean age, gender composition, and race / ethnic proportions in trials compared to the US cancer population. Enrollment Incidence Ratios (EIR), Enrollment Incidence Disparities (EID), and χ2 tests were used to analyze the data. Results and Conclusion: The results underline substantial gender, age, ethnicity, and race disparities in clinical trial participation across the five cancer types. The overrepresentation of male participants and members of the 18-65 age group, as well as the underrepresentation of Asian and Black communities, underscores the significance of diversifying representation to ensure a more comprehensive evaluation of CAR-T cell therapies for the spectrum of cancers. Keywords: disparities, clinical trials, immunotherapy, CAR T-cell
| Item Type: | Doctoral Capstone Project |
|---|---|
| Subjects: | R Medicine > RA Public aspects of medicine |
| Divisions: | Radford University > Waldron College of Health and Human Services > Health Sciences Program |
| Date Deposited: | 09 Feb 2024 05:31 |
| Last Modified: | 09 Feb 2024 05:31 |
| URI: | http://wagner.radford.edu/id/eprint/1092 |
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