Mays Cancer Center at UT Health SA

UT Health SA 梅斯癌症中心

• 批准号: 10653970
• 负责人: Chul Soo Ha
• 金额: $ 12.21万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10653970
• 关键词: Area; Authorization documentation; Budgets; Cancer Center; Charge; Clinical; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Collaborations; Committee Membership; Data; Discipline of Nursing; Disease; Doctor of Medicine; Doctor of Philosophy; Drug Kinetics; Ensure; Evaluation; Focus Groups; Health; Institutional Review Boards; Logistics; Malignant Neoplasms; Monitor; Peer Review; Pharmaceutical Preparations; Pharmacy facility; Physicians; Population; Process; Protocols documentation; Recommendation; Research; Resources; Review Committee; Risk Assessment; Safety; Site; Structure; System; Work; authority; clinically relevant; dosage; expectation; innovation; interest; operation; pre-clinical

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.

项目摘要--议定书审查和监测系统 议定书审查和监测系统(PRMS)监督并确保优先次序、可行性、 梅斯癌症中心(MCC)所有临床研究的科学价值和进展。PRMS由两个部分组成 审查阶段，以及后勤和可行性审查。这些组件中的每一个都协同工作 相互合作，以确保以适当的资源对适当的人群进行适当的审判。 由九个临床疾病现场小组(CDST)执行对方案和优先顺序的初步审查， 医生领导的小组专注于特定的疾病地点或感兴趣的领域。科学的严谨性和进步是 由议定书审查委员会(中华人民共和国)评估。PRC评估协议的统计准确性， 并综述了药物剂量的合理性、创新点、临床前数据、影响和意义等与癌症相关的研究 审判。虽然不是PRMS的一部分，但临床试验操作委员会(CTOC)审查了 可行性、安全性和物流。PRMS评估流程在提交给UT Health SA之前进行 机构审查委员会(IRB)，并需要获得IRB的批准。重要的是，PRMS流程是 与内部审查委员会的审查相辅相成，并不重叠或重复各自的职责。这个 未经中华人民共和国批准，IRB不会批准协议。在对应计项目开放研究后，中华人民共和国 提供持续的审查，以确保充分的应计和科学进步。中华人民共和国有权关闭 没有朝着预期的科学目标前进的研究。2018年，MCC PRMS委员会 回顾了78项试验。在这些研究中，77项获得批准并开始计提，1项未获批准，2项研究 因缺乏进展/应计而关闭。