Biomarkers: Bridging Pediatric and Adult Therapeutics (R21)
Deadline: Standard NIH Deadlines
Amount: The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
This Funding Opportunity Announcement (FOA) encourages grant applications that propose adapting adult biomarkers to children. This would include the application and validation of biomarkers developed in adults to pediatric diagnosis, prognosis, and estimation of disease progression, toxicity and response to therapy. Projects supported by this FOA will include those biomarkers that correlate with a clinical observation, have been extensively studied in adults, and for which there is solid evidence that they have pediatric applications. Discovery of new biomarkers for use in new drug development or in preclinical studies is also part of this FOA.
- A biomarker has been defined as a characteristic that is objectively measured and evaluated as indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to therapeutic interventions (Biomarkers Definitions Working Group, NIH (Clin. Pharmacol. Ther. 2001, 69:89-95).
- This FOA will foster collaboration between pediatric and adult medicine investigators in related disciplines
- The proposed research may use animal models in support of pediatric studies, stored clinical samples or new clinical testing.
- The use of multi-disciplinary teams is strongly encouraged in order to test the use, in pediatrics, of adult biomarkers and bring new ideas, expertise and methodologies.
- The studies proposed in response to this FOA may require the resources of a clinical trial. Some applicants may be investigators of a parent clinical trial(s) whose data and/or materials and/or subjects they propose to use. PDs/PIs who are not parent study investigators should work together with the parent study investigators in developing their applications.
- Applicants can propose planning activities and pilot studies for validation of biomarkers that have shown early promise for use in pediatrics, with the goal that these biomarkers could be tested in larger clinical trials. They may also propose ancillary studies to ongoing or completed clinical trials.