TAS::75 0850:: RECOVERY ACT - ACTNOW

为了确保癌症治疗评估计划(CTEP)能够履行其作为IND赞助商的责任，CTEP研究抗癌药物的药物开发支持合同向CTEP研究药物处(IDB)和监管事务部(RAB)提供了与这些责任相关的多个领域的援助。这些工作包括：1)协助起草和组织研究用新药申请(IND)；2)复制所有IND提交的材料并提交给FDA和合作者；3)维护ND修正案提交、规程、FDA通信跟踪、合作研究和开发协议(CRADAS)、临床试验协议(CTA)以及IND状态的数据库；4)接收、处理和执行对不良反应的初步评估，必要时要求提供适当的补充数据，并准备提交FDA的书面不良事件报告，并将副本提供给药物合作者。 癌症治疗和诊断部(DCTD)主要通过其癌症治疗评估计划(CTEP)，赞助几个独特的机制来开展早期抗癌治疗开发。新的肿瘤路径加速临床试验(ActNow)计划的重点是通过加快近30项新的临床治疗试验的开发来加快进展。由于ARRA提供的资源，加速的时间表是可能的。ARRA基金将帮助NCI的工作人员支持加快启动这30项临床试验的时间表。资金将被添加到CTEP支持合同中，包括合同“CTEP的药物开发支持”。

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."