RECOVERY - ACTNOW Clinical Trial Support under Operation and Support of the Cancer Therapy Evaluation Program's Clinical Trials and Information Management Support

This action modifies an existing contract to provide funding for ACTNOW clinical trial support. This contract provides information support, database administration, data management, statistical support, and operation office requirements in support of clinical trials. Support includes compilation, collation, summarization, and analysis of data as well as literature and database searches and retrieval. In addition, contractor staff creates and/or maintains databases to track information concerning NCI-sponsored clinical trials.

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.