RECOVERY - "ACTNOW Clinical Trials Support provided under the CTEP contract for Drug Development Support"

This action modifies an existing contract to to provide funding for ACTNOW Clinical Trial support. This contract is in place to assure that the Cancer Therapy Evaluation Program (CTEP) is able to fulfill its responsibilities as an Investigational New Drug (IND) sponsor to NCI in meeting the IND regulations of the United States Food and Drug Administration. The following support is provided: assistance in drafting and organizing IND applications; making copies of all IND submissions and delivering them to the FDA and collaborators; maintaining databases for IND amendment submissions, protocols, FDA communications tracking, Cooperative Research and Development Agreements (CRADAs) and Clinical Trials Agreements (CTAs) as well as IND status; and 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. Rationale for other than Fixed Price: The primary purpose of the contract is to support the development of cancer clinical treatment trials sponsored by CTEP, NCI. The number of patients enrolled in each clinical trial is estimated at the start of the trial, but may fluctuate during the course of the study. In addition, the complexity of the protocols varies due to the phase, disease to be studied, drug(s) to be used and the statistical design of the trial. The uncertainties involved with enrolling human participants and the complexities of protocol development make it difficult to predict the amount of services required to support the clinical trials. Uncertainties involved in contract performance do not permit costs to be estimated with sufficient accuracy to use any type of fixed price contract. As such, a cost-reimbursement type action is appropriate.