The National Institute of Neurological Disorders and Stroke (NINDS) seeks grant applications for preliminary investigations leading to optimal clinical trials to treat or prevent neurological disease.*
The objective of this program announcement is to enhance the quality of clinical research to evaluate the interventions for the treatment or prevention of neurological disease. Research proposals should directly address how the preliminary study will advance the design of a subsequent definitive clinical trial for efficacy.
Potential areas of research interest include studies to: optimize the intervention strategy (e.g., dose, duration, frequency of dosing); investigate dose-concentration, dose-response, or concentration-response relationships contributing to optimal dosage selection for definitive trials; assess the appropriate delivery system or parameter settings of an electronic device or surgical technique; assess the safety and tolerability at various doses or concentrations of a specific intervention; evaluate whether an intervention produces sufficient evidence of short-term activity (e.g., biomarker activity) in humans as to justify an efficacy trial; select the best of two or more potential interventions or dosing regimens to evaluate in a subsequent definitive trial, based on tolerability or evidence of biological activity; and identify inclusion and exclusion criteria to be applied in the phase III clinical trial.
For more information, potential applicants should contact Dr. John Marler, Associate Director for Clinical Trials, NINDS, Neuroscience Center, 6001 Executive Boulevard, Room 2216, Bethesda, MD 20892; telephone: 301-496-9135; fax: 301-480-1080; e-mail: firstname.lastname@example.org.
*For a more detailed description of this program announcement, please visit the NIH web site at: http://grants.nih.gov/grants/guide/pa-files/PAR-03-174.html.