NINDS Neuroscience Funding Announcements

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Clinical Trials Methods in Neurology
Release Date: March 22, 2005
Announcement Number: NOT-NS-05-005

Funding Contact: NINDS Funding
Program Area: Contracts Management Branch, Office of Clinical Research
Also See:  http://www.ninds.nih.gov/funding/funding_announcements/NIH-NINDS-05-01.pdf

Brief Description:
The National Institute of Neurological Disorders and Stroke (NINDS) has a requirement to develop, conduct and evaluate a course of intensive training in clinical trial methodology for neurology research. 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 def initive 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. Specific goals of the contract are as follows: (1) to develop scientific content, curriculum, and format of a comprehensive, hands-on 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.

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