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

This grant, called "Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants," does not allow for clinical trials. The aim of the grant, outlined in a Notice of Funding Opportunity (NOFO), is to fast-track the translation of assays from research to the clinic. These assays, which can be methods, technologies, or tests, have been supported by the National Cancer Institute (NCI).

The NOFO is particularly focused on adapting and validating markers for use in the clinical environment. These markers - also known as biomarkers - are molecular, cellular, or imaging markers. The objective is to use them for various purposes, including cancer detection, diagnosis, prognosis, monitoring, response prediction in treatment, as well as for cancer control and prevention.

Applicants may propose research projects for this grant that plan to acquire well-annotated specimens (from either NCI-supported or other clinical trials or observational cohorts/consortia). These specimens will be used to validate the clinical relevance of the assay.

The grant encourages an interdisciplinary approach, fostering cooperation between scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. It is suggested that clinical laboratory scientists and statistical experts play an integral role in the project.

Please note that this NOFO does not provide support for early-stage technology development or the execution of clinical trials. Instead, it aims to adapt and validate assays to the level where they can be integrated into clinical trials as investigational assays, tools or devices.