NINDS PILOT THERAPEUTICS NETWORK CLINICAL OPERATIONS CENTER: NPTUNE COC RELEASE DATE: April 30, 2004 NOTICE: NOT-NS-04-013 RFP Available: NIH-NINDS-RFP-04-05 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) The National Institute of Neurological Disorders and Stroke (NINDS) is seeking to form a network to perform pilot clinical trials for neurological diseases. Recent progress in neuroscience has led to an explosion in potential pharmacological interventions for neurological diseases that require testing in clinical trials. NINDS is supporting initiatives for drug screening and pre-clinical testing (http://grants.nih.gov/grants/guide/pa-files/PAR-02-139.html ). However, many interventions may never reach early phase clinical trials. There are several barriers to entry for pilot clinical trials, including issues of competing interventions, infrastructure and funding, access to patient populations, lack of experienced clinical investigators, and inadequate communication between pre-clinical and clinical researchers. The goal of this project is to ensure that potential treatments are tested in pilot clinical trials in a timely and efficient way by developing a network of sites under a single operations center that could implement small scale trials for different neurological diseases. The trials conducted by this network would be studies that are needed to gain the information about the intervention (such as the dose, kinetics, route of administration, safety, and preliminary evidence of activity) needed to design a phase III trial. The proposed network will be a resource to test promising new agents that result from pre-clinical translational research efforts. The overall objective of the network is to facilitate the timely transition from pre-clinical to clinical studies. Within the network, academic-based and practice-based centers could be pre-qualified, based on simple criteria, to be eligible to participate in pilot trials for one or more diseases. The goal is to have broad participation and representation of different populations and diseases to limit the barriers for sites to enter the network. New sites would be invited to apply to the network at regular intervals. The contractor will maintain eligible sites that may then compete to participate in specific, fully funded studies as the need arises. Each year, the network will potentially run two (2) or more concurrent pilot studies. There will be a single operations center that will work with investigators to develop protocols, consent documents and case report forms, facilitate compliance with regulatory requirements, train and monitor study sites, perform data management and analysis, and coordinate all aspects of the network. It is anticipated that the pilot studies will involve disease areas with little or no previous experience in clinical trials, requiring intellectual leadership clinical and statistical on the part of the operating center. The selection of particular interventions for study will be performed by an external advisory committee comprised of NIH staff and scientists independent of the centers in the network. The network will expedite clinical testing for select, high priority agents and provide clinical trials infrastructure where needed. It is anticipated that one performance based type contract will be made for a period of five (5) years in October, 2004. This is not a Request for Proposals (RFP). THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. Request for Proposal (RFP) No. NIH-NINDS-04-05 will be available electronically and may be accessed through the FedBizOpps (URL: http://www.fedbizopps.gov) or through the NINDS website at the following URL address: (http://www.ninds.nih.gov/funding/funding_announcements/RFP_all.htm) 15 or more calendar days after the issuance of this synopsis. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency. Refer to number note 26. ***** INQUIRIES Inquiries may be directed to: Helene Braun, Contract Specialist Contracts Management Branch National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 3287 6001 Executive Boulevard, MSC 9531 Bethesda, MD 20892-9531 Tel: (301) 496-1813 Fax: (301) 402-4225 Email: hb106s@NIH.GOV

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