NOT-NS-03-008: NINDS PILOT CLINICAL TRIALS NETWORK

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NINDS PILOT CLINICAL TRIALS NETWORK RELEASE DATE: May 5, 2003 NOTICE: NOT-NS-03-008 National Institute of Neurological Disorders and Stroke (NINDS) The National Institute of Neurological Disorders and Stroke (NINDS) is seeking information that may be used to help develop specifications for a network for pilot clinical trials and those organizations that might be capabilities to conduct such an effort. NINDS is seeking input about the technical expertise required and available to create and operate an efficient network, as well as input into its specific structure. Background 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 and a coordinating center that could implement trials for different neurological diseases. The trials conducted by this network would be studies that are needed to determine if further clinical testing of the intervention is warranted. The proposed network will be a resource for investigators 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, hundreds of academic-based and practice-based centers would be pre-qualified, based on simple criteria, 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 be added to the network at regular intervals. Sites would be maintained in the network at minimal cost, then compete to participate in specific fully funded studies as the need arises. Each year, the network will potentially start two or more pilot studies. There will be a single coordinating 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, and perform data management and analysis, and coordinate all aspects of the network. It is anticipated that the network will perform studies in disease areas in which few if any previous clinical trials have been performed. Thus, substantial flexibility and intellectual leadership clinical and statistical will be required on the part of the coordinating center. The selection of particular interventions for study will be performed by a steering committee comprised of NIH staff and scientists independent of the centers in the network. Participation in the network will not replace existing grants or contracts to perform clinical studies, nor should it discourage independent investigators or existing networks or cooperative groups from applying for funding. The network will expedite clinical testing for select, high priority agents and provide clinical trials infrastructure where needed. The major aims of the network are: 1. to facilitate the transfer of pre-clinical research results to clinical trials. 2. to minimize the cost of the infrastructure by building a network for several disease areas. 3. to make study of rare neurological diseases economically feasible 4. to expedite recruitment of subjects. 5. to involve a wide spectrum of investigators . 6. to recruit a broad range of participants, particularly minorities. 7. to make participation in NINDS clinical research more accessible to patients. These aims must be achieved while maintaining the highest ethical standards in human subject research, setting a benchmark for the entire neurology research community. Information Requested Information in the areas listed below will aid in the design of a solicitation to establish and operate the network. We request that interested organizations identify their technical expertise and resources, and capabilities and describe their availability to conduct such an endeavor. 1. Design and structure of the network a. What are the major essential components of the network? What expertise, capabilities, and levels of effort are required for each of the network centers and for the coordinating center? b. Should the network included centers capable of performing phase I studies in healthy subjects? c. What are the barriers to participation of neurological disease treatment centers in this endeavor? d. What steps (or phases) are necessary for initiation of the network? What is the proposed timeline? e. What should the criteria be for selecting treatments to be studied in this network and how should this selection process be organized? f. How can outreach and recruitment of children, women, and minority participants be implemented? g. How can outreach and recruitment of uncommon disease populations be implemented? h. What low-cost effort would sustain the capability of centers in the network to compete for the opportunity to participate in studies when the opportunity arises? i. Only a small fraction of centers would ever participate in any trials. What benefits would there be for the network centers that do not successfully compete to participate in trials sponsored by NINDS? 2. Subcontract Award and Management The pilot trial network may involve hundreds of investigators funded through small awards issued by the contractor as subcontracts. Describe the personnel and database requirements associated with awarding and managing multiple subcontracts, including quality control procedures, and research support services. 3. Program Management and Evaluation Initiating the network will be a complex and multifaceted process. The contractor will additionally be required to evaluate the progress of the subcontracted research and of the efficiency of the network. a. Describe your experience with strategic planning and initiation of comparably complex projects. b. Describe the technical, medical, and clinical methodological expertise that you possess that is necessary for the design, operation, and maintenance for the network. c. Describe how you would evaluate the overall performance of the network at each stage of its development. d. Describe your resources for organizing training and planning sessions for the investigators. 4. Personnel For the following, assume that at any time several hundred network centers would be qualified in one or more disease areas and that one or two 30-100 patient early to middle development studies would be started per year, each study to last 2 years or less. The number of centers to participate would vary widely depending on the scarcity of patients. The costs at each center would have to vary based on the number of patients they could be expected to provide. Provide an assessment of the number and mix of personnel required to create and operate the network and the approximate level of effort required, broken down by its major components. This Request for Information is for planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of the responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Respondents will not be notified of the Government's evaluation of the information received. Should a proposed solicitation materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so indicated. All respondents are asked to indicate the type and size of your business or organization, i.e. Large Business, Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, educational institution, or other profit or non-profit organization. Responses should be identified with RFI No. NS-03-008 and are due by June 16, 2003. Please submit three (3) copies of your response to: Laurie A. Leonard Contracting Officer Contracts Management Branch National Institute of Neurological Disorders and Stroke National Institutes of Health 6001 Executive Boulevard, Room 3282 Bethesda, MD 20892-9531 (for express mail/courier, use: Rockville, MD 20852) Email responses will also be accepted at: LL44S@nih.gov

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