NOT-NS-04-015: CLINICAL TRIAL METHODS IN NEUROLOGY REQUEST FOR INFORMATION (RFI): NS 04-015

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CLINICAL TRIAL METHODS IN NEUROLOGY REQUEST FOR INFORMATION (RFI): NS 04-015 RELEASE DATE: August 19, 2004 NOTICE: NOT-NS-04-015 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) The National Institute of Neurological Disorders and Stroke (NINDS) is considering issuing a contract to develop a course of intensive training in clinical trial methodology for neurology research. NINDS is attempting to identify sources with experience and expertise to develop and coordinate the scientific design and implementation of such training. Background The proposed idea is for development and implementation of a short course in clinical trial methodology targeted to junior neurology/neurosurgery faculty and fellows. Good design and conduct of clinical trials can provide definitive answers about the effectiveness of new therapeutic approaches. This can lead to promising avenues of research that are based on sound basic scientific work and lead to the introduction of new treatments into the general practice of neurology and neurosurgery. The field of neurology clinical trials is still fairly young and there is a need for more medically-trained researchers with appropriate methodological training. Currently, training in clinical research methodology that is typically provided by undergraduate and post-graduate medical education programs and fellowships is not adequate for developing future leaders in neurology clinical trials. The proposed course is intended to provide the essential basics that will help the trainees make the transition from an interesting research question to a well- planned research protocol. Similar courses in other disciplines (e.g., oncology, cardiovascular disease) often incorporate lectures, panel discussions, and working sessions over an intensive training period of 1 to 2 weeks. The course agenda for this program is intended to focus on general as well as neurology-specific concepts in clinical trials design and conduct and to provide students with hands-on experience in developing a clinical trials protocol. Neurology and neurosurgical clinical fellows and junior faculty will be invited to apply to attend the course. To be most effective, we expect the training course to be conducted at least annually. Evaluation of course quality and impact will be a significant component of the proposed initiative, with the results to be incorporated into subsequent years programs and curricula. We also want to stress the importance of methodology and training in minority populations and investigators. It is anticipated that this course will yield a group of talented, dedicated neurology researchers who will consequently be in a position to obtain funding for their own high quality clinical research. If the program is successful, it is anticipated that trainees will return to their academic departments where they will take a prominent role in advancing local research priorities in neurology. Goals of the Contract The purpose of such a Clinical Trial Methods in Neurology course is to increase the reliability and effectiveness of clinical trials by: introducing clinical fellows and junior faculty in any neurology or neurosurgical subspecialty to the principles of good clinical trial design; exposing early career clinical scientists to the full spectrum of challenges in clinical research; and developing a cadre of well- trained, experienced clinical researchers whose expertise will foster better clinical trials design and thereby hasten the introduction of improved regimens for therapy and prevention of neurological disorders into everyday medical practice and patient care. Specific goals of the contract are: 1. To develop scientific content, curriculum, and format of the training program. 2. To organize and conduct the training program, including recruitment and selection of faculty and participants. 3. To conduct formal evaluation of the training program. Information Requested Information in the following areas will aid in the design of the proposed solicitation. We ask that interested organizations identify critical criteria to be included in the solicitation. The information supplied in response to this request need not be limited to these areas. o General scientific approach to identifying content and developing and implementing the training program; o General scientific approach to on-going evaluation of the training program; o Overall estimation of the number of personnel required and specific expertise needed, with approximate level of effort required for each; o Availability of technology; o Project timeline; o Your organization’s capability as it relates to this project. This Request for Information (RFI) is for information and 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 responses nor otherwise pay for the preparation of any information submitted or the Government’s use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government’s evaluation of the information received. However, should such a requirement 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 marked. All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Veteran- owned Small Business, Service-disabled Veteran-Owned Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization. Responses should be identified with NINDS RFI No. 04-015 and are due by September 9, 2004. Please submit four (4) copies of your response to: Ida Lirette Contract Specialist or Laurie Leonard Contracting Officer Contracts Management Branch National Institute of Neurological Disorders and Stroke NIH 6001 Executive Boulevard, Room 3287 MSC 9531 Bethesda, Maryland 20892-9531. (for FedEx or courier, use: Rockville, MD 20852) Phone number: (301) 496-1813 Fax number: (301) 402-4225 E-mail responses, sent to il26v@nih.gov, will also be accepted.

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