Early Phase Pain Investigation Clinical Network: Greater New York Clinical Center

PROJECT SUMMARY/ABSTRACT In some patients, acute pain progresses to chronic pain. In the United States, more than 50 million adults suffer from chronic pain. Treatment options for pain are limited. An over-reliance on opioids for acute and chronic pain has contributed to the opioid epidemic. New, safe pain therapeutics are needed to address the dual public health crises of chronic pain and opioid misuse and addiction. The Greater New York Clinical Center (GNYCC), under the shared leadership of Dr. Lisa Doan and Dr. Richard Lipton, aims to engage experts in pain research and pain practice to build the infrastructure required to support the objectives of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). The GNYCC will provide expertise and resources to perform phase 2 clinical trials to test the efficacy of novel pain treatments, as well as phenotyping and biomarker studies that will enable customized treatments. Our consortium comprises four major academic centers in New York City, one of the most diverse cities in the US and the nation's largest metropolitan area. Care delivery sites include major private hospital centers, specialized orthopedic hospitals, public hospitals, children's hospitals, and the VA. All affiliated academic centers also have Clinical and Translational Science Awards (CTSA) programs. Cross-CTSA collaboration enables us to pool the sites' collective expertise in study design, community engagement, and patient recruitment and retention which will contribute to the success of the GNYCC. Our team of investigators and clinicians come from different specialties and have multiple areas of expertise, including trial design and execution as well as biomarkers and precision medicine. We will 1) build infrastructure to rapidly access clinical trial resources and a network of investigators and clinical leaders; 2) develop a plan for swift evaluation and launch of proposed studies; and 3) optimize patient retention and monitor sites to ensure protocol adherence, data quality, and efficiency. The GNYCC has access to incredible diversity in demographics, disease, and care-delivery, and has access to a deep bench of experts in pain research and pain practice. We are well equipped to contribute to EPPIC-Net by providing scientific leadership and infrastructure to design and conduct phase 2 clinical trials and both phenotyping and biomarker studies.