Yale School of Medicine, Yale University, New Haven, Connecticut, USA CTSA Service Center, Mayo Clinic, Rochester, Minnesota, USA.
Clin Transl Sci. 2010 Dec;3(6):305-8. doi: 10.1111/j.1752-8062.2010.00246.x.
The Clinical and Translational Science Award (CTSA) Consortium Workshop was conceived as a venue to foster communication among academic medical centers (AMCs) in the development of methods to improve clinical research management. The consortium, comprised of 46 awardee sites as of 2009, many with multiple AMCs, is expected to expand to 60 sites when fully implemented. At the 2nd Annual CTSA Clinical Research Management Workshop held on June 22nd and 23rd , 2009, on the National Institutes of Health (NIH) campus, consortium members and potential CTSA sites gathered with stakeholders from private industry, the NIH, the Food and Drug Administration, and private research organizations, to formulate a plan to address challenges in clinical research management. Specific aims included improving protocol processing and sharing process improvement initiatives in the expectation that best practices will be implemented and improvements will be measured and reported. The findings presented at this workshop indicated significant variance in Institutional Review Board approval of protocols and contract execution by AMC and CTSA sites. Most represented marked delays compared to non-AMC sites and that, as a likely consequence, AMCs were later to enroll patients and/or meet enrollment targets compared to dedicated or professional sites.
临床与转化科学奖（CTSA）联盟研讨会的构想是为了促进学术医疗中心（AMC）在开发改善临床研究管理方法方面的交流。该联盟由 2009 年的 46 个获奖机构组成，其中许多机构都有多个 AMC，预计在全面实施后将扩大到 60 个机构。在 2009 年 6 月 22 日至 23 日在国立卫生研究院（NIH）校园举行的第二届 CTSA 临床研究管理研讨会上，联盟成员和潜在的 CTSA 站点与来自私营企业、NIH、美国食品和药物管理局以及私人研究组织的利益相关者聚集在一起，制定了一项计划来应对临床研究管理方面的挑战。具体目标包括改进方案处理和共享流程改进举措，期望实施最佳实践并衡量和报告改进。该研讨会提出的研究结果表明，机构审查委员会对协议的批准以及 AMC 和 CTSA 站点的合同执行存在显著差异。与非 AMC 站点相比，大多数站点的代表明显延迟，因此，与专用或专业站点相比，AMC 招募患者和/或达到招募目标的时间较晚。
