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OpenR01Clinical trial: Not allowed

Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)

National Institutes of Health (NIH) · NIH Institute/Center · PAR-24-304

Source: Grants.gov · View original posting ↗

Award
Amount not listed
Deadline
Oct 14, 2026
Letter of intent
Mechanism
R01
Duration
Expected awards
Funding cycle
Standard NIH dates
Open date
Oct 10, 2024
Total funding
Clinical trial
Not allowed
Established investigatorSmall businessHigher educationGovernmentNonprofitForeign entities

Funding context

16%of applications funded

Based on FY2024 NIH (all institutes) R01 applications (5,385 of 33,139 applications awarded).

Institute-specific data wasn’t available — showing the NIH-wide rate for this mechanism.

Payline: NIH discontinued percentile paylines for 2026 under its Unified Funding Strategy ↗ — scores are now weighed in context rather than against a fixed cutoff.

NIH-wide R01, all institutes.

Aggregate historical data by institute, mechanism, and fiscal year — context for planning, not a prediction for this opportunity. Source ↗

Research areas

Basic mechanisms & biologyBiomarkers & diagnosticsTherapeutics & drug discoveryClinical trialsPrevention & risk factors

Auto-classified from the title and description (keyword-based) — may be imperfect.

Description

Through this Notice of Funding Opportunity (NOFO) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic. Specifically, the focus of this NOFO is on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" r "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer control and prevention. Research applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed for this NOFO encourage multi-disciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.

Data notes: award amount not published in the source feed; administering NIH institute could not be identified from the opportunity number.