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Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)

National Institutes of Health

The purpose of this notice of funding opportunity (NOFO)is to enable clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. Specifically, the goal of this PAR is to enable the rigorous clinical validation of biomarker measurements within the clinical population of interest to establish the clinical sensitivity and specificity of the biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.
Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

The NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

Transdisciplinary research projects and collaborations among neuroscientists and researchers from fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.
Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
Individual applications and partnerships that enhance geographic and regional heterogeneity.
Investigators and teams composed of researchers at different career stages.
Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
Opportunities to enhance the research environment to benefit early- and mid-career investigators."

Companion FOAs:

PAR-24-095 , U01 Research Project (Cooperative Agreements)
PAR-24-096 , U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II
PAR-24-098 , U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II

Deadlines:

Letter of Intent Due Date(s): 30 days prior to the application due date
Application Due Date(s): March 22, 2024; June 21, 2024; Feb 21, 2025; June 20, 2025; Feb 20, 2026; June 22, 2026

PAR-24-097 Expiration Date June 23, 2026