HEAL Initiative: Discovery of Biomarkers and Biomarker Signatures to Facilitate Clinical Trials for Pain Therapeutics (UG3/UH3 Clinical Trial Optional)

Background
The purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery of strong candidate biomarkers or biomarker signatures for pain that can be used to facilitate the testing of non-opioid pain therapeutics in Phase II clinical trials. The biomarkers or biomarker signature will be developed through clinical research specifically focused on the identification of pain biomarkers or biosignatures that predict and/or monitor response to pain therapeutics. This FOA is part of the NIH HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis.

Grant Details
The resulting biomarkers or biomarker signatures may be focused on a single pain condition or on several pain conditions with common underlying pathophysiology. Applications should feature MPI-led teams that represent each of the related pain conditions and associated clinical networks.

Applications should also feature centralized resource groups that will coordinate clinical trials and standardize all sample or data collection methods, technology development, statistical analysis, and algorithm development across the pain conditions under investigation. Studies to be supported by this FOA may include those necessary for the identification and initial biological, analytical, and clinical validation of pain biomarkers or biomarker signatures, and must include human samples and data as the source for candidate biomarkers or signatures identification and development if possible.

Eligibility Requirements
Higher Education Institutions, Nonprofits, For-Profit Organizations, Small Businesses, Local Governments, State Governments, County Governments, City or Township Governments, Special District Governments, Indian/Native American Tribal Governments are eligible to apply.

Period of Performance
The UG3 phase will support preparatory studies including activities such as study planning and finalization of team organization along with initial sample collection.

The UH3 phase will support continued method development, algorithm development and further analytical, biological, and clinical validation as the signature or algorithm is developed. The UG3 phase may last for two years while the UH3 phase cannot exceed three years.

Grant Value
Application budgets are limited to less than $500,000 in direct costs per year for the UG3 phase and up to $1,500,000 in direct costs per year of the UH3 phase. NIH intends to issue 2-3 awards in 2022, 5-6 awards in 2023 and 3-4 awards in 2024 under this FOA.