DCTD Translational Research Initiative

NCI支持用于治疗癌症患者的新药开发的早期临床试验。确定用于治疗干预的分子靶点，以及针对这些靶点的药物，正在改变药物开发的范式。这使得相关和成像研究有必要与这些早期临床试验一起进行，以便记录原则证明，并指导其他临床试验策略。2001年初，CTEP/NCI建立了TRI，以资助在CTEP研究新药(IND)药物的赞助临床试验期间进行的相关和成像研究。该NCI计划服务于校外社区，支持与参与NCI赞助的临床试验的患者的材料或检查相关的关键研究。自2002年2月以来，一直向CTEP/NCI的翻译研究倡议提供行政支助。建立了高效的合同前和合同后机制 开发用于奖励执行相关和成像研究的机构。截至2007年8月，已向51个不同的机构授予了281项合同(254份合同和27份额外的基本订购协议)，承付款总额超过1800万美元。在过去的一年里，特别努力鼓励所有分包商按照合同准则开具发票，以便 可以更好地估计各财政年度的成本和方案资金的可获得性。此外，从2007年1月开始，开始对所有分包合同进行重新评价，以评估拟议的相关研究工作的优先次序，以便通过TRI继续供资。在审查、协调、收集和传播这次全面审查的数据方面付出了相当大的努力。这项审查对于向药物调查指导委员会提供信息以及评估该计划当前和未来的财政义务是必要的。

The NCI supports early clinical trials for novel agent development for the treatment of patients with cancer. The identification of molecular targets for therapeutic intervention, and of agents directed at those targets, is altering the paradigms for drug development. This has made it necessary for correlative and imaging studies to be performed in conjunction with these early clinical trials in order to document proof-of-principle, and to direct additional clinical trial strategies. In early 2001, CTEP/NCI established the TRI to fund correlative and imaging studies performed during the conduct of sponsored clinical trials of CTEP Investigational New Drug (IND) agents. This NCI program serves the extramural community to support critical correlative studies with material from or examinations of patients participating on NCI-sponsored clinical trials. Administrative support has been provided to CTEP/NCI's Translational Research Initiative since February 2002. An efficient pre- and post-contract mechanism has been developed to award institutions performing the correlative and imaging studies. As of August 2007, 281 awards (254 contracts plus 27 additional basic ordering agreements) had been made to 51 separate institutions, totaling more than $18 million committed. During the past year, special effort was taken to encourage all subcontractors to invoice according to contract guidelines, so that the accounting of costs across fiscal years, and the availability of programmatic funds could be better estimated. Additionally, starting in January 2007, a re-evaluation of all subcontracts was initiated to assess the priority of the proposed correlative study work for continued funding through the TRI. Considerable effort was utilized to review, coordinate, gather, and disseminate the data from this comprehensive review. This review was necessary to provide information to the Investigational Drug Steering Committee, and to evaluate the current and future fiscal obligations of the program.