UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center

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Project Summary The purpose of this grant submission is the proposal of the University of Pennsylvania Health System patient care structure as a Specialized Clinical Centers (SCC - "hubs") of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIH's Helping to End Addiction Long- term (HEAL) Partnership. EPPIC-Net will provide a robust and readily accessible infrastructure for the rapid implementation and performance of high-quality, comprehensive studies of patients with well-defined pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain. Using the Hospital of the University of Pennsylvania as a HUB and 5 additional centers that are part of the UPenn Health system and the Children's Hosptial of Philadelphia (CHOP) as Spokes, studies will be conducted as designed by the expertise of the EPPIC network, which intends to bring intense focus to relatively small numbers of patients with clinically well-defined pain conditions and high unmet therapeutic needs. Studies may be performed in either adult or pediatric populations. The UPenn SCC expects to be testing novel, efficient study designs including adaptive and platform designs, validation studies of biomarkers, and biomarker-informed proof of principle or target engagement studies in Phase 2 trials of interventions from academic and industry partners. The UPenn site will assist the EPPIC-Net to make clinical, neuroimaging, biomarker, and preclinical data, as well as biosamples, available through public access data and biospecimen repositories. It is anticipated that EPPIC-Net will be able to run up to five clinical trials concurrently, in addition to deep clinical phenotyping and biomarker validation studies. The SCC will be expected to work collaboratively with the other SCC as well as the EPPIC-Net Clinical Coordinating Center (CCC) and Data Coordinating Center (DCC). The UPenn-SCC has ready access to patient populations with specific pain conditions, including low back pain, and have expertise in their characterization. Additionally, UPenn- SCC HUB will provide scientific leadership and administrative oversight to its 6 satellite sites (“Spokes”). The current proposal is for the establishment of the UPenn-SCC HUB and Spokes, and identification of potential populations but will not include funding for any of the clinical trials to be conducted. This will be negotiated later in a separate contract with the EPPIC Network and NIH.