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Analytical and/or Clinical Validation of a Candidate Biomarker for Pain (R61/R33 Clinical Trial Optional)

The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the validation of strong candidate biomarkers and endpoints for pain that can be used to facilitate the development of non-opioid pain therapeutics from discovery through Phase II clinical trials. Specifically, the focus of this FOA is on advanced analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints using retrospective and/or prospective methods. It is assumed 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. Research supported by this FOA will ultimately demonstrate that biomarker or endpoint change is reliably correlated with variables such as clinical outcome, pathophysiologic subsets of pain, therapeutic target engagement or response to a pain therapeutic; in addition, biomarker response will demonstrate specificity to the pain condition or therapeutic as demonstrated at multiple clinical sites. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers, biomarker signatures and endpoints of pain to application in clinical trials (Phase II clinical trials and beyond) and in the spectrum of clinical practice.

Funding Opportunity Details


Teresa L.Z. Jones, M.D.

Key Dates


30 days prior to the application due date

November 27, 2018; March 7, 2019; November 25, 2019; March 12, 2020 by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.