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NOT-NS-18-057 The National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Data Coordinating Center (DCC) for a new Clinical Trials Network on Pain Research (CTNPR). This CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.

The CTNPR will enable exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain.  These trials may validate biomarkers, provide proof of mechanism, and otherwise contribute to the justification for and provide the data required for designing a future Phase 3 trial.  The specific pain conditions will include well-defined ones with high unmet needs and more common, chronic neuropathic, inflammatory or nociceptive pain disorders in adult and pediatric populations. The network will also implement clinical studies for biomarker discovery and validation, and will store biomarker data and samples for future biomarker discovery.  It is anticipated that the CTNPR will be able to run as many as five Phase 2 trials concurrently in addition to biomarker validation studies. Further, it is anticipated that a number of the investigational drugs, biologics, and devices tested may come from private companies or academics.   

The DCC will have responsibility for web-based data collection, data management and quality assurance, statistical design and analysis, and reporting to the Data and Safety Monitoring Boards and regulatory and oversight groups.  More importantly, the DCC will be expected to provide innovative statistical leadership to the CTNPR with the goal of accelerating the discovery and evaluation of treatments for pain. The DCC will also house a data repository and biosample repository. It is envisioned that the DCC will also serve as the convener of an Expert Panel that consists of objective subject matter experts with experience in developing therapeutics. This Expert Panel would serve as the liaison to private companies who may contribute therapeutics to the CTNPR for testing. These analyses will be submitted to an NIH Scientific Review committee for prioritization.