Clinical Trial Methods In Neurology

Notice Number: NOT-NS-06-007

Key Dates
Release Date: April 7, 2006

Issued by
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.

The field of neurology clinical trials is still fairly young; unlike in oncology and other disciplines, there is no highly developed standard for clinical trial methodology, especially with respect to pilot or early phase trials. Good design and conduct of clinical trials can provide the necessary knowledge for the generation of definitive answers about the effectiveness of new therapeutic approaches. In contrast, poorly designed or administered trials may provide misleading results, subject patients to unnecessary risk, waste considerable resources, and potentially diminish the interest of the research community and the public in the clinical trials enterprise. The need for more medically-trained researchers with appropriate methodological training has been identified as an important limiting factor in the scope and quality of clinical research overall and specifically in neurology.

The purpose of the “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.

It is anticipated that this annual 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 students will return to their academic departments where they will take a prominent role in advancing local research priorities in neurology. To achieve this objective, NINDS requires a high-impact program for training future researchers that is innovative and that exceeds all other training experiences available to those treating neurological disease. Currently, more than half of the NINDS extramural clinical trials budget is spent on early phase (phase I, II and pilot) trials. However, the majority of trials supported through the NINDS pilot study program have not made use of the full range of available trial designs and thus have not been as effective as possible in leading to high-impact definitive clinical trials. Thus, the primary focus of this solicitation will be on developing researchers with expertise in early phase clinical trials.

Specific goals of the contract are as follows: (1) to develop scientific content, curriculum, and format of a comprehensive, hands-on training program incorporating innovative methods of teaching and conducting clinical trial research and taking advantage of knowledge gained in disciplines outside of neurology, with emphasis on early phase/pilot trials; (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 and, where relevant, incorporate results into subsequent course offerings. Specific requirements of the contract are: (1) develop course content; (2) organize and offer course; (3) recruit course participants; (4) conduct evaluation of training program; and (5) plan, organize, and conduct subsequent training course sessions.

It is anticipated that one cost-reimbursement type contract will be made for a period of five years in February 2007. This is not a request for Proposals (RFP). THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. Request for Proposal (RFP) No. NIH-NINDS-06-03 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/currentrfps.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.


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