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Publication Date - 12/3/1999

19. NIH/NIDCR - Clinical Trial Pilot Grant

The National Institute of Dental and Craniofacial Research (NIDCR) announces a call for pilot clinical studies. The objective of the NIDCR Clinical Trial Pilot Grant is to address preliminary design and methodological issues for specific clinical trials used to evaluate interventions for the treatment or prevention of craniofacial, oral, and dental conditions and promotion of craniofacial, oral, and dental health.

These pilot grants may support studies to refine the intervention strategy (e.g., dosage, duration, delivery system); develop and test surrogate endpoints of disease or health; develop diagnostic criteria and/or survey instruments; establish measures of safety or efficacy; and/or develop organizational structures including a field-tested manual of operations. It is expected that results of pilot studies will optimize design of the eventual full-scale trial.

The support mechanism will be the NIH research project grant (R01). Grants for single center trials may not exceed $500,000 per year in total costs (direct costs plus facilities and administrative) for three years. Each enrollment center in multi-center trials and the coordinating center may apply separately or the coordinating center may apply on behalf of itself and each enrollment center. The total cost for each enrollment center may not exceed $250,000 and for the coordinating $35,000, each per year for three years. The award may not be renewed.

Applications are due FEBRUARY 1, JUNE 1, or OCTOBER 1, 2000.

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