New Experimental Medicine Studies: Fast-Fail Trials in Psychotic Spectrum Disorders (FAST-PS)

Analysis was performed in accordance with FAR Sections 16.103(d)(10;16.302(b),16.306(b) and 35.006(b) and (c) provisions of the Duncan Hunter National Defense Authorization Act of 2009. As recognized by FAR 35.005, the biomedical/behavioral services that are being procured under this contract are, by their nature, research activities. On one hand, the Contractor must have flexibility to be creative in its technical approach as it performs the work. On the other, The Government must have authority to control and direct changes as they evolve. Our requirements are not commercial, off-the-shelf items, or standard professional services; they buy science. Advancing state-of-the-art science necessarily must allow for "fluid" performance and substantive changes to the cost of performance as an inherent part of R&D. The Government must reserve the right to direct research efforts and to avoid having an inflexible Statement of Work that does not meet the research needs. In consideration of this flexibility, The Government also must then assume some risk in structuring the contract on a cost-reimbursable basis. NIMH/NIA R&D CMB cannot fix in advance the exact nature and extent of the work covered by the proposed contract and the precise method of performing the work. The work is subject to improvisation because of unknown and unpredictable changes as the work progresses. The Contracting Officer's Representative (COR) wrote the scope of work for this R&D project to facilitate technical achievement of an overall goal through innovation and creativity. Accordingly, this project's work statement does not include many specific design or performance metrics. The science approach to achieve the goal could change based on early results, and thus, must allow for unplanned changes as work continues.