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

This contract amendment provides funding for the ACTNOW Clinical Trial numbered 8418, focusing on early therapeutic research primarily through Phase 2 and pilot clinical trials of agents sponsored by the National Cancer Institute (NCI). The trials aim to assess the biological impact of these agents on molecular targets, explore promising combination therapies, and determine clinically relevant outcomes that are crucial for drug development. The emphasis is on rapid initiation, completion, and data reporting for high priority studies pivotal to advancing treatment options. The contract reimburses the contractor based on patient accrual, with payments made per patient enrolled, reflecting the unpredictability in accrual numbers which precludes the use of a fixed price contract model. Additionally, cost reimbursement provisions cover non-patient care costs, addressing the uncertainty in overall expenses related to contract performance. The contract, designated under solicitation number N01-CM-62201 and titled "RECOVERY - ACTNOW 'Early Therapeutics Development with Phase II Emphasis,'" utilizes NAICS code 541711, indicating its focus on research and development in biotechnology. The actions undertaken through this funding will support critical Phase 2 studies and exploratory pilot protocols that could accelerate the development and evaluation of new cancer treatments. Points of contact for this contract include Contract Specialist Michael P. Marino and Contracting Officer Richard L. Hartmann, who manage communications and contractual oversight. The structured approach balances fixed price payments per patient with cost reimbursement elements to ensure flexibility in managing variable clinical trial costs.