The National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Child Health and Human Development (NICHD), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute of Mental Health (NIMH) invite grant applications for research on biomarkers and clinical endpoints in pediatric clinical trials.
In the last 3 years, major drug legislation and regulatory events have occurred that will profoundly affect pediatric drug development in the future. An increase in the number of drug studies has brought to light the problem of finding enough children to conduct efficacy trials. Another identified problem is the difficulty in establishing efficacy and safety of drugs used in the treatment of chronic childhood conditions because of the lack of adequate markers to establish disease severity, recurrence, and response to therapy.
Potential areas for research include: identification, development, validation, and/or extrapolation from adult trials of biomarkers of diagnosis, prognosis, and disease activity; study of treatment effects on additional outcome variables not included in the adult trial; development of genetic biomarkers and genetic databases using samples and data from trial subjects; estimation of the magnitude of treatment effect on validated adult biomarkers that reflect underlying pathogenesis; development of statistical methodology to establish the validity of surrogate endpoints in pediatrics; and development of biomarkers for pain assessment in infants that are more sensitive and specific than current pain scales and can be used to determine drug effects accurately.
For more information, potential applicants should contact Dr. Giovanna Spinella, Program Director, Neurogenetics Cluster, NINDS, Neuroscience Center, 6001 Executive Boulevard, Room 2132, Bethesda, MD 20892; telephone: (301) 496-5745; fax: (301) 402-1501; e-mail: firstname.lastname@example.org.
For a more detailed description of this program announcement, please visit the web site at: http://grants.nih.gov/grants/guide/pa-files/PA-01-043.html.