Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network

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Project Summary The objective of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) and EPPIC- Net initiatives is to rapidly and efficiently translate advances in the neurobiology of pain into treatments for people with chronic and acute pain, conditions associated with a significant burden to both patients and society. Challenges to the successful and efficient development of novel treatments for people with pain include inefficiencies in regulatory and institutional submissions and approvals, a variety of barriers to recruitment of subjects that slow down clinical research, inadequate quality assurance of trials, and a shortage of individuals trained and prepared to participate in and lead multicenter trials. The primary goal of the Clinical Coordinating Center (CCC) for EPPIC-Net is to promote and facilitate, from initial conception through final analysis, clinical trials in adult and pediatric populations with acute or chronic pain by providing efficient methodological, organizational and logistical support. The EPPIC-Net-CCC will adopt and establish processes aimed at dramatically increasing the efficiency of multicenter clinical trials, improving the overall quality of clinical trials, promoting patient recruitment and retention as well as increasing the number of clinical investigators and research staff well trained and passionate about leading and conducting multicenter clinical trials. The Specific Aim 1 of our proposal is to harness through a collaborative Clinical Coordinating Center multidisciplinary clinical research and data management expertise to provide the scientific leadership and infrastructure required to design and conduct multi-site Phase 2 clinical trials, biomarker validation studies, and deep phenotyping of patient populations to understand the biologic basis of a specific pain condition and its response to treatment. The Specific Aim 2 of our proposal is to expand the pool of experienced clinical Investigators and research staff to be participants and leaders of multicenter clinical research trials by providing education, training, resources and professional mentorship. Finally, the Specific Aim 3 of our proposal is to engage and mobilize federal, industry, foundations and patient partners by working with the EPPIC-Net Steering Committee (EPPIC-Net-SC), EPPIC-Net-DCC and Project Team Principal Investigators to conduct multi-site Phase 2 clinical trials, biomarker validation studies, and deep phenotyping of patient populations to understand the biologic basis of a specific pain condition and its response to treatment.