NIH to Fund Pediatric Biomarker Studies



September 01, 2011

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The National Institutes of Health sees a need for biomarkers that are or may be useful in adults to be further developed for use in children, and it has opened a new funding program aimed specifically at such research.

Through three new funding announcements, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Nursing Research seek to support studies that would investigate the use or adaptation in children of biomarkers tested for adults.

The studies could involve a wide range of research approaches and use a variety of types of biomarkers.

The three grant programs NIH will use to support the program include R01 research project grants of up to five years with no pre-set budget, R03 small grant program awards of up to $ 50,000 per year, and R21 exploratory/developmental grants of up to $ 275,000 over two years.

Researchers may propose using or validating biomarkers developed in adults for use in pediatric diagnosis, prognosis, and estimation of disease progression, toxicity, and response to therapies.

The biomarkers NICHD and NINR view as valuable for further study under this program would correlate with a specific clinical observation, have been extensively studied in adults, and have solid evidence supporting their potential application in pediatrics. Research aimed at discovering new biomarkers for use in drug development or preclinical studies will not be considered.

Investigators seeking funding may propose planning activities or pilot studies, or they may propose ancillary studies to ongoing clinical trials. NIH also is encouraging the use of multidisciplinary teams to test the use of adult biomarkers in pediatric subjects.

The research could include a broad range of pursuits, including but not limited to identifying or using biomarkers for diagnosis, prognosis, and disease activity; applying genetic or other novel diagnostic biomarkers for diagnosis of a disease or condition; applying adult cDNA, microarray, proteomics, and metabolomics biomarkers; studying biomarkers to assess immune responsiveness in children compared to adults; studying novel sepsis biomarkers in pediatric subpopulations; and application or adaptation of non-invasive toxicity biomarkers to detect subtle liver, kidney, or central nervous system damage for a specific drug or therapeutic class, among others.