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.""""""""
