RECOVERY - ACTNOW Clinical Trial Support under Operation and Support of the Cancer Therapy Evaluation Program's Informatics and Computer Support

This action modifies an existing contract to provide funding for ACTNOW clinical trial support. This contract implements and maintains the Cancer Therapy Evaluation Program's (CTEP) Enterprise System which includes capturing data and translating it into a usable format to address the scientific, safety, regulatory and administrative needs of CTEP and the NCI in conducting clinical trials; streamlining clinical research operations; improving communication between CTEP and its collaborators; assuring the security and confidentiality of proprietary and patient information; increasing access to clinical trials to all investigators; and, supporting broad patient access to clinical trials and expediting the protocol development and review process within both clinical trial organizations and reviewing bodies. Rationale for using other than a fixed price: 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. 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 of the study, 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. DUNS 606270015