TAS::75 0850:: RECOVERY ACT - ACTNOW

为了确保癌症治疗评价项目（CTEP）能够履行其作为IND申办者的职责，CTEP研究性抗癌药物药物开发支持合同为CTEP研究药物分支（IDB）和法规事务分支（RAB）提供了与这些职责相关的多个领域的协助。这些包括：1）协助起草和组织研究性新药申请（IND）; 2）复制所有IND提交资料并将其提交给FDA以及合作者; 3）维护ND修正案提交资料、方案、FDA通信跟踪、合作研发协议（CRADA）和临床试验协议（CTA）以及IND状态的数据库; 4）接收、处理和进行AE的初步评估，如果需要，要求适当的补充数据，并准备书面不良事件报告提交给FDA，并将副本提交给制药合作者。 癌症治疗和诊断部（DCTD）主要通过其癌症治疗评估计划（CTEP）赞助了几种独特的机制来进行早期抗癌治疗的开发。加速新型肿瘤途径临床试验（ACTNOW）计划的重点是通过加速大约30项新的临床治疗试验的开发来加速进展。由于ARRA提供的资源，加快的时间轴是可能的。ARRA的资金将帮助NCI的工作人员支持加快时间轴安装这30个临床试验。资金将增加到CTEP支持合同，包括合同，“药物开发支持CTEP。"

In order to assure that the Cancer Therapy Evaluation Program (CTEP) is able to fulfill its responsibilities as an IND sponsor, the CTEP Drug Development Support Contract for investigational anti-cancer agents provides the CTEP Investigational Drug Branch (IDB) and the Regulatory Affairs Branch (RAB) with assistance in a number of areas related to these responsibilities. These include 1) assistance in drafting and organizing Investigational New Drug Applications (INDs); 2) making copies of all IND submissions and delivering them to the FDA, as well as collaborators 3) maintaining databases for ND amendment submissions, protocols, FDA communications tracking, Cooperative Research and Development Agreements (CRADAs) and Clinical Trials Agreements (CTAs) as well as IND status; 4) receiving, processing, and performing an initial assessment of AEs, requesting appropriate supplemental data if required and preparing written adverse event reports for submission to the FDA, with copies to pharmaceutical collaborators. The Division of Cancer Treatment and Diagnosis (DCTD), primarily through its Cancer Therapy Evaluation Program (CTEP), sponsors several unique mechanisms to carry out early anticancer therapy development. The Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) program is focused on accelerating progress by speeding the development of approximately 30 new clinical treatment trials. The accelerated timeline is possible due to the resources provided by ARRA. ARRA funds will assist NCI staff in supporting the accelerated timeline for mounting these 30 clinical trials. Funds will be added to CTEP support contracts including the contract, "Drug Development Support for CTEP."