Racial disparities and inequity in clinical trials of chimeric antigen receptor T-cell therapy.

Abstract

e18515 Background: Chimeric antigen receptor (CAR) T-cell therapy is a paradigm-shifting advancement in hematologic malignancies with therapeutic futility. There is growing evidence that there are disparities affecting race and ethnicity for malignancy treatments as well as under-representation of minorities in clinical trials. We analyzed the racial representation in clinical trials of CAR-T products in the US. Methods: We searched all clinical trials in PubMed for six FDA-approved CAR-T therapy for all indications. We included all phase 2 and above published trials that were conducted in the US and recorded demographic data. Results: Out of total 64 studies; 16 were included for final analysis. A total of 1678 patients enrolled in the CAR-T therapy trials. The table shows indication and demographic data of the patient. Only 9 (56%) articles reported race and 8 (50%) articles reported ethnicity. We found only 47 (3%) African Americans, 47 (3%) Asian races, and 53 (3%) Hispanic ethnicity patients were enrolled in the trials. Conclusions: Our study highlights inadequate reporting of race/ethnicity and continued under-representation of minorities in clinical trials. This is the largest study examining the generalizability of CAR-T cell therapy RCTs at a population level. The underrepresentation in RCTs is an alarming finding as the incidence of many of the diseases is quite high in such minority populations thus exposing a significant disparity in health equity and healthcare access. More insights through research and policymaking are necessary to overcome barriers to delivering equitable healthcare, especially to underrepresented minorities.[Table: see text]