Mays Cancer Center at UT Health SA

计划摘要-研究计划检讨及监察系统 方案审查和监测系统（PRMS）监督并确保方案的优先次序、可行性、 Mays癌症中心（MCC）所有临床研究的科学价值和进展。PRMS包括两个 审查的各个阶段，以及后勤和可行性审查。这些组件中的每一个都协同工作 确保为拥有适当资源的适当人群开放和积累适当的试验。 由9个临床疾病研究中心小组（CDST）对方案和优先顺序进行初步审查， 由医生领导的小组专注于特定的疾病部位或感兴趣的领域。科学的严谨和进步 由方案审查委员会（PRC）评估。PRC评价方案的统计准确性， 药物剂量和审查的合理性，创新，临床前数据，影响和意义的癌症相关 审判虽然不是PRMS的一部分，但临床试验运营委员会（CTOC）审查以下方案： 可行性、安全性和后勤保障。PRMS评估过程在提交给UT Health SA之前进行 机构审查委员会（IRB），需要IRB批准。重要的是，PRMS流程 作为IRB审查的补充，同时进行，并且不重叠或重复其职责。的 未经PRC批准，IRB不得批准方案。在研究开始应计后，PRC 提供持续审查，以确保适当的应计费用和科学进展。中华人民共和国有权 没有朝着预期科学目标进展的研究。2018年，MCC PRMS委员会 审查了78项试验。其中，77项研究获得批准并开放招募，1项未获得批准，2项研究 因缺乏进展/应计费用而关闭。

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.