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

The National Institute of Dental and Craniofacial Research (NIDCR) intends to reissue a Notice of Funding Opportunity (NOFO) to solicit applications for observational or biomarker validation studies that require prospective collection or continued analysis of data/biospecimens. Well-designed, adequately powered, and well-executed clinical studies that prospectively collect data and/or biospecimens have the potential to generate robust results and advance the knowledge base to improve dental, oral and craniofacial health. Longitudinal studies allow for exposure assessment and its relation to disease development. A biomarker validation study aims to confirm the utility of strong candidate biomarker measures or endpoints—supported by robust preliminary data—for diagnosis, prognosis, monitoring, and/or predicting response to treatment. Study design examples 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. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise in clinical research or biomarker validation studies are encouraged to consider applying for this new NOFO. NIDCR is authorized to forecast this opportunity under the Public Health Service Act (42 U.S.C §§ 241 and 284) and federal regulations (42 CFR Part 52 and 2 CFR Part 200).