UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center

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Project Summary The purpose of this diversity supplement submission is to fund Ms. Danielle Kellier's participation in our Specialized Clinical Centers (SCC - "Hubs") of the Early Phase Pain Investigation Clinical Network (EPPIC- Net) to learn about the design, conduct, and analysis of clinical trials for pain therapies and to contribute her expertise in the social determinants of health and passion for increasing diversity in research to the overall process. Ms. Kellier is currently enrolled in our Epidemiology PhD program as part of her MD/PhD program at the University of Pennsylvania and is not funded by any other NIH grant. EPPIC-Net is an important component of the NIH's Helping to End Addiction Long-term (HEAL) Partnership designed to provide a robust and accessible infrastructure for the rapid design and conduct of high-quality, comprehensive Phase 2 clinical trials of promising novel therapeutics for pain in well-defined pain conditions. The Hospital of the University of Pennsylvania (Hub) and 6 additional Penn Health system centers (Spokes) has been selected as one of the Specialized Clinical Centers (SCC) charged with conduction well designed studies to bring intense focus to pain patients (both adult and pediatric) with high unmet therapeutic needs. The Penn SCC expects to test novel therapeutics using efficient study designs including adaptive and platform studies, validation studies of biomarkers, and biomarker-informed proof of principle or target engagement studies in phase 2 trials of products from academic and industry partners. The Penn SCC will make clinical information, neuroimaging, biomarker, preclinical data, and bio-samples available through public access data and biospecimen repositories in collaboration with the other SCCs, the EPPIC-Net Clinical Coordinating Center (CCC), and Data Coordinating Center (DCC). The Penn-SCC has ready access to a broad range of patient populations with specific pain conditions and has expertise in their characterization. The Penn-SCC Hub will also provide scientific leadership and clinical trial expertise to the HEAL-EPPIC net program. An important component of the HEAL-EPPIC Net is the testing of novel therapeutics in a diverse population and significant effort is being put into the recruitment and enrollment of subjects from under-represented groups. Ms. Kellier has a substantial interest and background in the social determinants of health and will be able contribute to the EPPIC-Net's efforts to increase the recruitment of patients from racial or ethnic minorities that are often underrepresented within clinical research. She will also design and complete her doctoral project identifying factors that characterize trends in health resource use patterns for children with primary headache and other pain disorders use electronic health record data, under the guidance of her mentors, Drs. John T. Farrar and Christina Szperka, with a target of an independently funded research career to improve care for underserved populations.