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

The NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed) supports investigator-initiated observational studies or biomarker validation studies requiring prospective data or biospecimen collection. This funding opportunity is managed by the National Institute of Dental and Craniofacial Research (NIDCR), which aims to advance research in dental, oral, and craniofacial health through rigorous clinical and translational studies. Applications must not involve clinical trials.

The program will support studies that generate high-quality data addressing disease prevalence, risk factors, treatment outcomes, or biomarker validation for diagnosis, prognosis, and treatment response. Eligible study designs include cohort studies, case-control studies with longitudinal follow-up, and large cross-sectional analyses focused on disease mechanisms, omics-based pathways, and treatment outcomes. Biomarker validation studies must focus on advanced analytic and clinical validation of biomarkers for which preliminary evidence already exists, demonstrating their utility in a specific clinical context.

Applications may propose multi-site observational cohort studies, biospecimen analysis for risk or treatment responses, or biomarker validation studies involving genomic, transcriptomic, proteomic, and metabolomic analyses. Projects that further utilize existing biospecimens or data are encouraged, as are those advancing predictive tools, standard-of-care evaluations, and natural history studies of disease mechanisms. Applications focused on biomarker discovery, including initial identification or preliminary validation, will be considered non-responsive and will not be reviewed.

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local and state governments, tribal entities, and faith-based or community-based organizations. Foreign organizations are not eligible, but foreign components of U.S.-based entities are allowed. Applicant organizations must meet all applicable registrations, including SAM, Grants.gov, and eRA Commons, and all program directors or principal investigators must have an eRA Commons account.

Application budgets are not limited but must reflect the project’s actual needs. The maximum project period is five years. Applications must include detailed plans for biospecimen collection, quality management, clinical data management, and a schedule of events for participants. The submission process requires adherence to NIH’s Application Guide, and all applications must comply with the NIH Data Management and Sharing Policy. Letters of intent, while optional, are encouraged to be submitted 30 days before the due date.

Proposals will be evaluated on three main factors: the importance of the research, rigor and feasibility of the approach, and the expertise of the research team and institutional resources. Applications must address the significance of the proposed study, provide a clear research question, justify study design and sample size, and demonstrate an effective plan for analysis and data collection. Biomarker validation studies must outline plans for analytic performance metrics, including sensitivity, specificity, and reproducibility.

Applications are due by February 5, 2025; June 5, 2025; October 5, 2025; and subsequent standard NIH due dates through May 8, 2026. Award notices are contingent on scientific merit, availability of funds, and alignment with NIDCR priorities. Selected projects will operate under cooperative agreements with substantial involvement from NIDCR staff, including guidance on study design, implementation, and monitoring. Recipients must comply with NIH reporting requirements, including annual progress reports and data sharing obligations.