CLINICAL TRIALS - PROTOCOL REVIEW MONITORING SYSTEM

临床试验 - 方案审查监测系统

• 批准号: 7944911
• 负责人: BRIAN LEYLAND-JONES
• 金额: $ 7.98万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-07 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7944911
• 关键词: Address; Basic Science; Behavioral Sciences; Cancer Center Support Grant; Cancer Patient; Chairperson; Clinical; Clinical Data; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical trial protocol document; Data; Data Reporting; Disorder by Site; Ensure; Goals; Institutes; Laboratories; Malignant Neoplasms; Monitor; Monitoring Clinical Trials; Patients; Pharmacology; Physician Executives; Protocols documentation; Reporting; Resource Sharing; Resources; Role; Safety; Scientific Evaluation; System; Therapeutic Studies; Translational Research; cancer care; experience; meetings; programs; statistics; working group

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.

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 是一个共享资源，通过提供科学审查，优先级排序和 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， WCI的癌症患者。PRMS的具体目标如下： 1)审查临床研究的新提案，以确保它们在科学上是有价值的， 解决重大的临床问题，并且有足够的患者和机构资源进行 研究建议。 2)优先考虑跨疾病部位的拟议临床研究，以满足WCI的目标 计划和完成高质量，高影响力的癌症临床研究的总体目标 患者 3)审查现有临床研究方案的科学进展，并终止方案， 应计率与达到所述科学目标不一致，或者新的科学数据 使审判变得不安全或不重要 4)监测临床研究实施期间获得的科学数据的准确性和及时性。 WCI PRMS由WCI临床试验办公室提供支持，包括临床和翻译 研究委员会（CTRC）由Tom Olson（主席）和Tom Heffner（副主席）担任主席， 经验丰富的临床研究者。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保持临床研究的科学完整性， 通过WCI CTO进行的研究，确保所解决的科学问题是 重要的是，这项研究将产生与癌症问题有关的新信息， 这项研究，包括应计率，足以回答它所处理的科学问题。的 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、安全性和监查委员会（DSMC）是数据、安全性和监查计划的一部分， WCI CTO。临床数据的准确性或及时性方面的任何重大违规行为均报告给WCI 医学总监并由CTRC审查。癌症研究所所长，WCI医学主任 首席技术官和各工作组主席每月收到关于 治疗研究以供审查。