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

This contract amendment provides funding for the ACTNOW Clinical Trials numbered 8121, 8252, and 8258, which focus on Phase 2 and early clinical trials of NCI-sponsored agents. The primary objectives are to evaluate the biological effects of these agents on their molecular targets, investigate other relevant biological impacts, and determine clinically relevant outcomes and correlates. Emphasis is placed on Phase 2 studies, pilot protocols exploring promising combination therapies, and high-priority investigative protocols essential for drug development that require rapid initiation, completion, and reporting of data. The core activity supported by this contract is early therapeutic research aimed at advancing drug development. Payments under this contract are based on patient accrual rather than a fixed price, due to the unpredictability of patient enrollment numbers. The contractor receives a fixed price per patient accrued, while most contracts also include cost reimbursement provisions for non-patient care expenses. Because of the uncertainties inherent in contract performance and the difficulty in estimating costs with precision, a cost reimbursement approach is deemed appropriate. The contract is associated with the solicitation number N01-CM-62206 and falls under NAICS code 541711, with points of contact including Contract Specialist Michael P. Marino and Contracting Officer Richard L. Hartmann.