RECOVERY - ACTNOW "Early Therapeutics Development with Phase II Emphasis"

This action modifies an existing contract to provide funding for ACTNOW Clinical Trial numbered 8461. The purpose of these contracts is to conduct Phase 2 and early clinical trials of NCI-sponsored agents, evaluate biologic effects of these agents on their molecular targets, evaluate other relevant biologic effects and determine clinically relevant outcomes/correlates. Major emphasis is on Phase 2 studies, pilot protocols that explore promising combination therapies, and high priority studies that are pivotal for drug development and require rapid initiation, completion, and data reporting. The principal activity funded under this program is early therapeutic research. Rationale for using other than a fixed price: These contracts reimburse the contractor on the basis of patient accrual. The number of patients accrued cannot be predicted with enough accuracy to justify a fixed price type contract, however, the Contractor is paid a fixed price for each patient accrued. Although the contracts have a fixed price cost per patient, most of the contracts include cost reimbursement provisions for non-patient care costs. Uncertanties 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.