PAR-25-239
NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
Summary
NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement
Research Focus
This funding opportunity supports investigator-initiated prospective observational studies and biomarker validation studies in dental, oral, and craniofacial health and disease. NIDCR seeks well-designed clinical studies that generate robust, high-quality data through systematic prospective collection of data and biospecimens or continued analysis of previously collected specimens. Eligible observational study designs include epidemiologic prevalence/incidence studies, prospective cohort studies assessing risk factors for disease development, longitudinal treatment outcome studies, and large cross-sectional or case-control studies evaluating genomic changes, gene-environment interactions, or disease mechanisms through -omics, cellular, and imaging analyses. Biomarker validation studies must advance analytic or clinical validation of strong candidate biomarkers with existing preliminary data, establishing accuracy, precision, sensitivity, specificity, reproducibility, and clinical utility for diagnosis, prognosis, monitoring, or prediction of treatment response. Biospecimen analyses may include epigenomic, transcriptomic, proteomic, cellular, metabolomic, imaging, and physiologic endpoints. Studies requiring large participant numbers and standardized biospecimen collection are prioritized. Discovery-phase biomarker work is not supported.
At a Glance
- Who can apply: Investigator-initiated teams at U.S. and international institutions; experienced statisticians and data coordinating centers strongly encouraged.
- Funding & project length: Not stated.
- Award mechanism: U01 Cooperative Agreement (clinical trials not allowed).
- Key dates: Applications due February 5, 2025 (earliest); subsequent cycles June 5 and October 5, 2025; February 5, 2026. Earliest start date December 2025 (first cycle).
- Best fit for: Epidemiologists, oral health researchers, and biomarker scientists conducting prospective cohort studies, longitudinal outcome assessments, or validation of candidate biomarkers in dental/craniofacial disease.
Key Facts
Deadline
Thu, May 7, 2026
Posted
Thu, December 5, 2024
Keywords
Research Areas
Gotchas (4)
Clinical trials are explicitly not allowed under this mechanism (U01 Clinical Trial Not Allowed), but the FOA permits 'long-term follow-up of clinical trial participants after a preventive or therapeu
85%
Source Text
“Research studies may be proposed for long-term follow-up of clinical trial participants after a preventive or therapeutic intervention, and the initial trial has ended... This NOFO will not support the biomarker and endpoint Discovery Phase...”
The FOA states that biomarker validation studies assume 'the initial discovery of the biomarker or assay will have been performed on a pre-existing set of human biospecimens' and that 'It is assumed t
90%
Source Text
“It is assumed that a candidate biomarker has been identified and assay technology or method of detection has been developed. Specifically, it is expected that the initial discovery of the biomarker or assay will have been performed on a pre-existing set of human biospecimens with the same disease or condition as that in the proposed validation application.”
The FOA explicitly states it will NOT support 'the biomarker and endpoint Discovery Phase, which may include initial identification, development of detection technology, and preliminary validation stu
95%
Source Text
“This NOFO will not support the biomarker and endpoint Discovery Phase, which may include initial identification, development of detection technology, and preliminary validation studies, such as initial analytic validation of the detection method along with studies designed to correlate modulation of the biomarker or endpoint with disease pathology, target engagement, or treatment response.”
The FOA strongly encourages pre-application consultation with NIDCR scientific staff ('strongly encouraged to consult with NIDCR Scientific/Research staff prior to beginning the application process'),
75%
Source Text
“Investigators considering preparing and applying are strongly encouraged to consult with NIDCR Scientific/Research staff prior to beginning the application process to determine NIDCR interest in the concept that would be proposed in the application.”