• The Pragmatic and Implementation Studies for the Management of Pain (PRISM) program will support studies to integrate interventions that have demonstrated efficacy into health care systems or implement health care system changes to improve adherence to evidence-based pain management guidelines. PRISM encourages cooperative research applications to conduct efficient, large-scale pragmatic trial or implementation science study designs to improve pain management. The program requires that the intervention under study be embedded into health care delivery system, real world settings. The pragmatic trial model collects most of data needed for analysis of the research question as part of clinical care, and it is expected that this data will be obtained primarily through the electronic records of the health care system. Studies needing to randomize participants individually, collect in-person measures for research purposes (such as clinical laboratory tests, observed studies of mobility or other measures of function) or deliver an intervention in a standardized fashion with fidelity monitoring should consider applying to the HEAL Pain ERN.
  • EPPIC-Net
    • The Early Phase Pain Investigation Clinical Network (EPPIC-Net) will provide infrastructure for the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain.  This network will support exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain. These trials may include deep phenotyping, validation of biomarkers, and proof of mechanism, to support justification and provide the data for designing a future Phase 3 trial.  The specific pain conditions of interests for EPPIC -Net include well-defined conditions with high unmet therapeutic needs in patients across the lifespan.
    • The NIAMS intends to launch the Back-Pain Consortium (BACPAC) initiative, a patient-centric translational research program focused on chronic low back pain. Back pain is a major contributor to the use of opioids in the US. The mechanisms of low back pain are likely to be complex, with a variety of organs, tissues and cell types interacting in an environment heavily influenced by mechanical, physical, biological and biopsychosocial factors that result in the experience of pain, a decrease in physical function and in emotional and social distress.  BACPAC will conduct studies that will dissect these components and mechanisms and integrate all new information to identify, prioritize and test new therapies targeted to specific mechanisms. The goal of this initiative is to probe the biomedical mechanisms of the disease in a biopsychosocial context using interdisciplinary methods and innovative technologies so that novel individualized targeted treatments can be developed, tested and combined for an integrated approach to eradicate chronic low back pain. This highly collaborative research program will conduct research to deliver an integrated model of low back pain and patient-based algorithms to facilitate the identification of treatments tailored to the individual patient.
    • The NINDS-NHLBI-NCIATS funded initiative, Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) runs clinical studies in the prehospital setting and the emergency department. It includes academic hub sites, spoke hospitals, and EMS providers to support multicenter clinical studies on neurological emergencies, including the prehospital and emergency department treatment of acute pain.
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Form Approved OMB# 0925-0648 Exp. Date 06/2024