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PCORI seeks to fund pragmatic clinical trials, large simple trials, or large-scale observational studies that compare two or more alternatives for addressing prevention, diagnosis, treatment, or management of a disease or symptom; improving healthcare system-level approaches to managing care; communicating or disseminating research results to patients, caregivers, or clinicians; or eliminating health or healthcare disparities. Proposed studies must address critical clinical choices faced by patients, their caregivers, clinicians, or delivery systems. They must involve broadly representative patient populations and be large enough to provide precise estimates of hypothesized effectiveness differences and to support evaluation of potential differences in treatment effectiveness in patient subgroups.

(RFA-NS-19-025 is being reissued to accommodate an additional receipt date). The purpose of this funding opportunity announcement (FOA) is to invite applications for the Specialized Clinical Centers (hubs) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIHs Helping to End Addiction Long-term (HEAL) Initiative. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs. EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (hubs). The purpose of this funding opportunity announcement (FOA) is to invite applications for the hubs within EPPIC-Net. A hub will typically be a regional medical center that will actively enroll subjects into clinical trials and studies performed in EPPIC-Net. Each hub should have ready access to patient populations with specific pain conditions and have expertise in characterization of that pain condition. A hub will additionally provide scientific leadership and administrative oversight to its multiple (2-10) satellite sites (spokes). This FOA solicits applications EPPIC-Net Specialized Clinical Centers. Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-18-036) and Data Coordinating Center (RFA-NS-18-035). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL Partnership, as described above, or from separate NIH funding announcements.

This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH), invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH awarding components identified in this FOA are encouraged to submit STTR grant applications in response to identified topics (see PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH.