Notice Number: NOT-NS-05-005

Key Dates
Release Date: March 22, 2005
RFP Release Date: April 1, 2005

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 p rogram; (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.

It is anticipated that one cost-reimbursement type contract award will be made for a period of five years beginning on or about September 30, 2005. This acquisition has been designated as full and open competition under the North American Industrial Classification System (NAICS) code 541710. The solicitation will be available electronically on or about April 1, 2005. RFP NIH-NINDS-05-01will be available at the FedBizOpps Website: http://www.fedbizopps.gov and at the NINDS public website: http://www.ninds.nih.gov/funding/funding_announcements/RFP_all.htm). Proposals will be due on or about May 16, 2005. Offerors are responsible for downloading their own copy of the solicitation and amendments and for routinely checking the Internet sites for any possible solicitation amendments that may be issued by the Government. All responsible sources may submit proposals which will be considered by the Government. This advertisement does not commit the Government to award a contract.

Inquiries

Inquiries may be directed to:

Ida Lirette
Contract Specialist, Contracts Management Branch, DER
National Institute of Neurological Disorders and Stroke, NIH
6001 Executive Boulevard
Suite 3287, MSC 9531
Bethesda, Maryland 20892-9531
Telephone: 301-496-1813
FAX: 301-402-4225
Email: IL26v@nih.gov

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