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Enrollment of Black Participants in Pivotal Clinical Trials Supporting US Food and Drug Administration Approval of Chimeric Antigen Receptor–T Cell Therapy for Hematological Malignant Neoplasms

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Key Points Question What is the proportion of Black participants enrolled in pivotal clinical trials supporting US Food and Drug Administration approval of chimeric antigen receptor–T cell (CAR-T) therapy for… Click to show full abstract

Key Points Question What is the proportion of Black participants enrolled in pivotal clinical trials supporting US Food and Drug Administration approval of chimeric antigen receptor–T cell (CAR-T) therapy for hematological malignant neoplasms? Findings In this cross-sectional study of data from 7 clinical trials that resulted in a subsequent Food and Drug Administration CAR-T therapy approval for hematological malignant neoplasms, the proportion of Black participants, adjusted to the disease prevalence, was suboptimal. Meaning The findings of this study suggest that disparities in the use of CAR-T therapy in clinical trials for hematological malignant neoplasms exist and are disproportionately affecting Black participants.

Keywords: clinical trials; food drug; malignant neoplasms; black participants; hematological malignant; drug administration

Journal Title: JAMA Network Open
Year Published: 2022

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