Protocal Review and Monitoring System

OSUCCC的方案审查和监测系统（PRMS）包括临床科学审查 委员会[CSRC]及其执行委员会[EC]，共同审查所有癌症相关临床 科学价值和监测科学进展的议定书，包括应计率。自上次PRMS以来 根据1999年的批准，中国证监会已重组为两个小组，以促进更快速的方案审查 并完善和澄清了科学进步的标准和优先顺序程序。中国证监会由 代表所有OSUCCC项目的24名成员，包括临床和基础研究人员， 生物统计学家、药剂师、一名病理学家、一名研究护士和两名患者倡导者。在双月会议上， 中国证监会对当地研究人员发起的所有癌症相关临床方案进行全面的科学审查 或制药业赞助商。在OSU Cancer审查之前，需要获得中国证监会的批准 机构审查委员会。正式审查需要三名成员，其中一名必须是 生物统计学家评审员遵循包含科学假设和基本原理的评审模板; 实验设计、患者入选和排除标准、治疗计划和统计学考虑， 确保符合所有审查标准。2003年期间，审查了60项新方案，其中12项[20%] 书面批准，40 [67%]有规定批准，8 [13%]推迟或撤回。正在进行 每六个月监测一次研究的科学进展。应计费用不足的定义是未能 在六个月内累计超过年度累计目标的50%。执行委员会 七名中国证监会成员每月开会，对提交的研究报告指派评审员，并协助中国证监会 确定研究优先事项和监测科学进展。如果存在竞争协议，EC 根据疾病特异性委员会的建议[即乳腺，肺， 血液学等]与研究者合作。中国证监会终止研究，不显示 在采取纠正措施后，或未能达到公认的质量控制标准后， 根据正式审计。

The Protocol Review and Monitoring System [PRMS] of the OSUCCC consists of a Clinical Scientific Review ICommittee [CSRC] and its Executive Committee [EC] that act together to review all cancer-related clinical IProtocols for scientific merit and to monitor scientific progress including accrual rates. Since the last PRMS lapproval in 1999, the CSRC has been reorganized into two teams to facilitate more rapid protocol review and has refined and clarified criteria for scientific progress and prioritization procedures. The CSRC consists of 24 members representing all OSUCCC programs and includes clinical and basic researchers, biostatisticians, pharmacists, a pathologist a research nurse and 2 patient advocates. At bimonthly meetings, the CSRC performs full scientific reviews of all cancer-related clinical protocols initiated by local investigators or pharmaceutical industry sponsors. CSRC approval is required prior to review by the OSU Cancer Institutional Review Board. Formal reviews are required by three members, one of who must be a biostatistician. Reviewers adhere to a review template that includes scientific hypothesis and rationale; experimental design, patient inclusion and exclusion criteria, treatment plan, and statistical considerations to ensure that all review criteria are met. During 2003, 60 new protocols were reviewed resulting in 12 [20%] approved as written, 40 [67%] approved with stipulations, and 8 [13%] deferred or withdrawn. Ongoing studies are monitored for scientific progress every six months. Inadequate accrual is defined as failure to accrue more than 50% of the annual accrual goals over a six-month period. The Executive Committee of seven CSRC members meets monthly to assign reviewers to submitted studies and to assist the CSRC in determining study priorities and in monitoring scientific progress. If there are competing protocols, the EC prioritizes the protocol based on the recommendation of disease specific committees [i.e. Breast, Lung, Hematology, etc.] in collaboration with the study investigator. The CSRC terminates studies that do not show adequate accrual after corrective measures are taken, or fail to meet accepted standards of quality control based on formal audits.