| HEAL Initiative: Discovery of Biomarkers and Biomarker Signatures to Facilitate Clinical Trials for Pain Therapeutics (UG3/UH3 Clinical Trial Optional)
02/08/2022 03:20 PM EST
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. The resulting biomarkers or biomarker signatures may be focused on a single pain condition or on several pain conditions with common underlying pathophysiology. Applications to identify biomarkers or biomarker signatures that predict or monitor a therapeutic response across several related pain conditions should feature Multiple Principal Investigator (MPI)-led teams that represent each of the related pain conditions and associated clinical networks. The MPI-led teams are expected to decide upon a single set of measures or biomarker modalities (i.e., combination of omics, QST, actigraphy, EEG, digital measures, etc.) as components of the biosignature for all pain conditions represented in the application. Applications should 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. Applications seeking to develop biomarkers or biomarker signatures that will be used to predict and/or monitor a therapeutic response for a single pain condition must also feature MPI-led teams that represent the cross functional expertise necessary for biomarker and/or signature development, along with the same types of centralized resource groups that coordinate clinical trials and standardize sample or data collection methods, technology development and statistical analysis.
Dana K. Andersen, M.D. | RFA-NS-22-050
Notice of Special Interest (NOSI): Administrative Supplements to Support Enhancement of Software Tools for Open Science
02/07/2022 07:20 PM EST
This Notice announces the continuing availability of administrative supplements to active awards that focus on biomedical software development or have a significant software development component. The goal of these supplements is to invest in research software tools with recognized value in a scientific community to enhance their impact by leveraging best practices and design principles in software development and advances in technology including cloud computing. This initiative is part of a plan for implementing the NIH Strategic Plan for Data Science which describes actions aimed at modernizing the biomedical research data ecosystem to make data findable, accessible, interoperable, and reusable (FAIR) and provide robust, scalable, sustainable tools and workflows with high impact for open science. The supplements are intended to support and encourage collaborations between biomedical scientists and software engineers to enhance the design, implementation, and cloud-readiness of research software. Through these awards, the NIH Office of Data Science Strategy (ODSS) intends to help researchers who have developed scientifically valuable software to make their tools robust and sustainable, take advantage of new data science, software engineering, and computing paradigms, reach a broader community and contribute to open science.
Fenglou Mao Ph.D.;Heidi Sofia Ph.D. | NOT-OD-22-068
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