CLINICAL TRIALS - PROTOCOL REVIEW MONITORING SYSTEM

Winship癌症研究所临床试验办公室(WCI CTO)的方案审查和监测系统 是一种共享资源，通过提供科学审查、优先排序和 监测涉及癌症患者的临床试验。WCI PRMS的长期目标是推进 通过确保临床研究的最高科学质量来促进癌症治疗的进展 世界癌症中心的癌症患者。PRMS的具体目标如下： 1)审查临床研究的新建议，以确保它们具有科学价值，并确保它们 解决重要的临床问题，并有足够的患者和机构资源进行 这项研究按建议进行。 2)对跨疾病地点的拟议临床研究进行优先排序，以实现世界卫生组织的目标 完成涉及癌症的高质量、高影响的临床研究的计划和总体目标 病人。 3)审查现有临床研究方案的科学进展，并终止下列方案 应计比率与所述科学目标的实现不一致，或者新的科学数据 使审判不安全或不重要。 4)监测在进行临床研究期间获得的科学数据的准确性和及时性。 WCI PRMS由WCI临床试验办公室支持，包括临床和翻译 由汤姆·奥尔森(主席)和汤姆·赫夫纳(副主席)担任主席的研究委员会(CTRC)，两人 经验丰富的临床研究人员。CTRC包括来自基础科学、临床研究、 生物统计学、药理学和行为科学。CTRC维护临床研究的科学完整性 通过WCI首席技术官进行的研究，确保正在解决的科学问题是 重要的是，这项研究将产生与癌症问题相关的新信息，并且 这项研究，包括应计比率，足以回答它正在解决的科学问题。这个 由临床方案生成的临床和实验室数据的准确性和及时性由 数据、安全和监控委员会(DSMC)，是数据、安全和监控计划的一部分 WCI首席技术官。临床数据的准确性或及时性方面的任何重大异常都会报告给世界卫生组织。 医务主任，并由反恐委员会审查。癌症研究所所长，世界卫生组织的医学主任 首席技术官和工作组主席每月收到关于主题应计费用的报告 供审查的治疗性研究。

The Protocol Review and Monitoring System of the Winship Cancer Institute Clinical Trials Office (WCI CTO) is a Shared Resource that supports clinical research by providing scientific review, prioritization and monitoring of clinical trials involving cancer patients. The long-term goal of the WCI PRMS is to advance progress in cancer care by ensuring the highest scientific quality of clinical research involving cancer patients at the WCI. The specific objectives for the PRMS are as follows: 1) To review new proposals for clinical research to ensure that they are scientifically meritorious, that they address significant clinical issues, and that there are sufficient patient and institutional resources to conduct the study as proposed. 2) To prioritize proposed clinical research across disease sites in order to meet the objectives of the WCI Programs and the overall goal of completing high-quality, high-impact clinical research involving cancer patients. 3) To review the scientific progress of existing clinical research protocols, and to terminate protocols in which accrual rates are inconsistent with meeting the stated scientific objective or in which new scientific data renders the trial unsafe or unimportant. 4) To monitor the accuracy and timeliness of scientific data obtained during the conduct of clinical studies. The WCI PRMS is supported by the WCI Clinical Trials Office and includes the Clinical and Translational Research Committee (CTRC) chaired by Tom Olson (Chairman) and Tom Heffner (Vice-Chairman), two experienced clinical investigators. The CTRC includes representation from basic science, clinical research, bio-statistics, pharmacology, and behavioral science. The CTRC maintains the scientific integrity of clinical research conducted through the WCI CTO by ensuring that the scientific question being addressed is significant, that the study will yield new information relevant to the cancer problem, and that the conduct of the study, including accrual rates, is sufficient to answer the scientific question that it is addressing. The accuracy and timeliness of clinical and laboratory data generated by clinical protocols is monitored by the Data, Safety, and Monitoring Committee (DSMC) that is part of the Data, Safety, and Monitoring Plan of the WCI CTO. Any major irregularities in the accuracy or timeliness of clinical data are reported to the WCI Medical Director and reviewed by the CTRC. The Cancer Institute Director, the Medical Director of the WCI CTO and the chairmen of the Working Groups receive monthly reports of accrual of subjects onto therapeutic studies for review.