Successful Implementation of a Chimeric Antigen Receptor T-Cell Risk Evaluation and Mitigation Strategies (REMS) Program

Abstract

Introduction Risk Evaluation and Mitigation Strategies (REMS) are required by the Food and Drug Administration to mitigate risks associated with select medications, including chimeric antigen receptor T-cell (CAR-T) products. Successful implementation of a CAR-T program includes compliance with REMS programs and associated audits. Objectives To effectively comply with CAR-T cell product REMS programs, the following roadmap for implementation is recommended. Methods Designation of an authorized representative with clinical and process improvement experience is paramount to successful implementation, in addition to provider and leadership engagement. An organized system of thorough record keeping with quarterly audits helps ensure accurate training and program maintenance records. Use of electronic medical record tools using discrete fields assists with standardized and consistent documentation. Finally, a proactive approach to audits with associated chart preparation leads to identification and resolution of existing deficiencies prior to inspections. Results Utilizing these strategies, an initial CAR-T cell product REMS audit was completed with zero citations, and a foundation was built for compliance with future reviews. Conclusion Several key techniques are critical to optimize compliance with CAR-T cell REMS programs.