Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)
Funding Agency:
- National Institutes of Health
This funding opportunity uses a R61/R33 Phased Innovation Award mechanism. The R61 phase will support biomarker and biomarker signature proof of concept studies to test a hypothesis that a candidate biomarker or biomarker signature is an indicator of a particular concept (a biological process or response to an intervention). Studies must use clinical samples, tissues, and/or data to evaluate the candidate biomarker or biomarker signature (animal studies are not allowed). Studies may also include optimization or additional development of the detection method including preliminary analytical validation needed to measure the biomarker/signature. The purpose of the R33 phase is to conduct preliminary clinical validation of the biomarker or biomarker signature for a specified Context of Use. Context of Use should include defining the category of biomarkers defined in the Biomarkers, EndpointS, and other Tools (Biomarkers, EndpointS, and other Tools (BEST) Resource and how it will be measured and used in clinical trials or clinical practice. Transition from the R61 to the R33 phase is contingent upon the successful completion of Go/No-Go milestones. The milestones should include the degree of association between the biomarker and the concept of interest needed to demonstrate potential clinical utility as well as the sensitivity, specificity, and internal validity of the detection method to measure the biomarker or signature. Milestones must be clearly defined, quantifiable, and scientifically justified to allow the investigator and program staff to assess progress in the R61 phase (Please refer to Project Milestones, end of Section I). Completion of a research project resulting from successful application to this FOA should result in a candidate biomarker or biomarker signature that meets the entry criteria for the companion FOAs supporting definitive analytical validation of the detection method (PAR-21-056, PAR-21-057) or definitive clinical validation (PAR-21-058, PAR-21-059).
Application budgets are not limited but need to reflect the actual needs of the proposed project.
June 22, 2022
Carol Taylor-Burds Ph.D, National Institute of Neurological Disorders and Stroke (NINDS), Telephone: 301-496-1779, Email: carol.taylor-burds@nih.gov