Neuroscience Biomarker Program

Purpose

Facilitate the development of high quality biomarkers to improve the quality and efficiency of clinical research (Phase II and beyond)

Overview

The NINDS Biomarker Program is dedicated to advancing biomarkers for neurological disease. It is focused on supporting research to promote biomarkers that will improve the quality and efficiency of clinical research toward Phase II and beyond.

To achieve this goal, the NINDS Biomarker Program will:

  • Promote the analytical and clinical validation of existing candidate biomarkers in a manner that is consistent with FDA guidelines and publications developed in collaboration with the NIH and the pharmaceutical industry
  • Catalyze biomarker research through the centralization of information on NIH-biosample and imaging repositories, information technologies, data collections, and best practice consensus standards and methods
  • Support research that incorporates high levels of quality, evidentiary standards, and implementation of best practices and consensus methods to ensure that data is useable and reproducible

Funding Opportunities

Current new funding opportunities focus on the advancement of candidate biomarkers to later stages of development, including analytical and clinical validation. 

Note:  Applications directed at developing biomarkers associated with pain or pain therapies are permitted to include aims related to biomarker discovery and identification in addition to aims related to analytical and/or clinical validation.  See notice NOT-NS-18-043.

Analytical Validation of a Candidate Biomarker for Neurological Disease

PAR-18-549:  U44

PAR-18-550:  U01

The purpose of these Funding Opportunity Announcements (FOA) are to support rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines.  Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.  These FOAs assume that 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding context of use is in place.  The goal of these FOAs is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond).

Clinical Validation of a Candidate Biomarker for Neurological Disease

PAR-18-548:  U44

PAR-18-664:  U01

The purpose of these Funding Opportunity Announcements (FOA) are to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. These FOAs assume that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of these FOAs is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II and beyond).