Planning Grant for Clinical Trial

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The NINDS encourages clinical research to evaluate interventions to treat and prevent neurological disease. The NINDS seeks to fund high quality clinical trials to evaluate treatments for neurological disorders. A grant has been established to provide support to investigators planning complex or large-scale clinical trials for the development of specific elements which will be essential to conducting a successful full-scale clinical trial, including adequate plans for recruitment of patients, experimental design and protocols, data management, analytical techniques, facilities, administrative procedures, and collaborative arrangements.

Detailed information regarding the rationale of the clinical trial, based on adequate, preclinical science and preliminary clinical research, must be developed prior to submission and included in the application. The purpose of the planning grant is not to obtain preliminary data or to conduct studies to support the rationale for the clinical trial. The expected product of the planning grant is a detailed clinical trial research plan including a complete manual of operations and procedures. The planning grant application must include a detailed study protocol [link to protocol template] and projected direct costs for the future definitive (phase III) trial. This estimate, broken down by year, should be included in the research plan of the application.

The NINDS Clinical Trial Planning Grant allows for early peer review of the rationale and design for clinical trials of treatments for neurological disorders.

Please note this PAR is in the process of revision. Please contact the Clinical Research Liaison for additional information.

Active Planning Grants
NINDS Clinical Trial Planning Grant (PAR-06-460)

 

Last updated April 20, 2007