CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

核心——方案审查和监控系统

• 批准号: 7100785
• 负责人: Thomas C. Shea
• 金额: $ 8.15万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7100785
• 关键词: biomedical facility; experimental designs; health services research tag; human subject; neoplasm /cancer therapy; patient safety /medical error

The principal component of the UNC Lineberger's Protocol Review and Monitoring Systems is the Protocol Review Committee (PRC), chaired by Dr. Tom Shea. The 28-person PRC meets bi-weekly and reviews every cancer-related clinical trial protocol before it is submitted to the OHRP-approved UNC School of Medicine Committee for the Protection of the Rights of Human Subjects (IRB). The PRC's primary function is to ensure the scientific quality and patient safety of proposed studies and determine study priority. The PRC also monitors study accrual and recommends closure of under-performing trials. The PRC works with the Data and Safety Monitoring Committee (DSMC) and the Oncology Protocol Audit Committee (OPAC) on review of patient safety and the proper conduct of a trial. Overall PRC use has been relatively steady or slowly growing over the past five years. While the number of new protocols reviewed has been relatively constant, the complexity of the studies has increased. With a continuing strategic emphasis on clinical research, novel therapeutics, and behavioral interventions, the Center expects increases in the number of new clinical trials initiated at UNC LCCC, as well as a continued increase in the quality, complexity, and intensity of the current trials. In addition, the Center has formalized a Phase I Developmental Therapeutics group under the leadership of Dr. Claire Dees. These trends will increase the number of new trials coming to the PRC and continue to increase the number of renewal applications.

Lineberger的方案审查和监测系统的主要组成部分是方案审查委员会（PRC），由Tom Shea博士担任主席。由28人组成的PRC每两周召开一次会议，审查每一项与癌症相关的临床试验方案，然后提交给OHRP批准的美国医学院保护人类受试者权利委员会（IRB）。PRC的主要职能是确保拟议研究的科学质量和患者安全，并确定研究优先级。PRC还监测研究累积，并建议关闭表现不佳的试验。PRC与数据和安全性监查委员会（DSMC）和肿瘤学方案审核委员会（OPAC）合作，审查患者安全性和试验的适当实施。 中国的总体使用相对稳定 或在过去五年中缓慢增长。虽然审查的新方案数量相对稳定，但研究的复杂性增加了。随着对临床研究，新型疗法和行为干预的持续战略重点，该中心预计在新的临床试验的数量增加，以及在质量，复杂性和强度的持续增加，目前的试验。此外，该中心还正式成立了由Claire Dees博士领导的I期发育治疗小组。这些趋势将增加进入中国的新试验数量，并继续增加续期申请数量。