NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)

This Notice of Funding Opportunity (NOFO) will support investigator-initiated observational studies or biomarker validation studies that require prospective collection of data/biospecimens or continued analysis of data/biospecimens. The goal is to advance the knowledge base to improve dental, oral, and craniofacial health. • The studies should be well-designed, adequately powered, and well-executed to generate robust results. • Longitudinal studies can allow for exposure assessment and its relation to disease development. • Biomarker validation studies aim to confirm the utility of strong candidate biomarker measures or endpoints for diagnosis, prognosis, monitoring, and/or predicting response to treatment. • Examples of study designs include prospective cohort or multi-site studies, post-trial follow-up of clinical trial participants to assess long-term adverse events, and advanced analytical or clinical biomarker validation studies.