Mays Cancer Center at UT Health SA

项目摘要-方案审查和监测系统

Project Summary—Protocol Review and Monitoring System The Protocol Review and Monitoring System (PRMS) oversees and ensures the prioritization, feasibility, scientific merit and progress of all clinical studies at the Mays Cancer Center (MCC). The PRMS consists of two stages of review, as well as a logistics and feasibility review. Each of these components work in collaboration with one another to ensure that the right trials for the right population with the right resources open and accrue. Initial review of protocols and prioritization is performed by the nine Clinical Disease Site Teams (CDSTs), physician-led groups focused on a particular disease site or area of interest. Scientific rigor and progress are evaluated by the Protocol Review Committee (PRC). The PRC evaluates statistical accuracy of the protocol, drug dosages and reviews the rational, innovation, preclinical data, impact and significance of the cancer-related trials. Though not part of the PRMS, the Clinical Trial Operations Committee (CTOC) reviews protocols for feasibility, safety and logistics. The PRMS evaluation process occurs prior to submission to the UT Health SA Institutional Review Board (IRB) and is required for IRB approval. Importantly, the PRMS process is complementary to the IRB review, occurs in tandem, and does not overlap or duplicate their responsibilities. The IRB will not approve a protocol without the PRC's approval. After a study has opened to accrual, the PRC provides ongoing review to ensure adequate accrual and scientific progress. The PRC has the authority to close studies that have not progressed toward their intended scientific objectives. In 2018, the MCC PRMS Committee reviewed 78 trials. Of those, 77 were approved and opened to accrual, 1 was not approved, and 2 studies were closed for lack of progress/accrual.