Medical University of South Carolina Specialized Clinical Center of EPPIC-Net

Medical University Of South Carolina, Charleston SC

Investigators

Abstract

Abstract/Summary Approximately 25 million people experience daily chronic pain and many are prescribed opioids for pain management. Effective treatment options are limited. It is critically important to study new treatments with the potential to better manage pain. The Medical University of South Carolina (MUSC) Specialized Clinical Center (Hub) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) will provide a robust and readily accessible infrastructure for rapid implementation and performance of high-quality, comprehensive studies of novel treatments for patients with a wide variety of pain conditions. The MUSC-Hub will harness multidisciplinary clinical, research, statistical, and data management expertise to provide the scientific leadership and infrastructure required to design and conduct multi-site Phase-II clinical trials, biomarker validation studies, and deep phenotyping of patient populations as part of the EPPIC-Net with the overall goal of accelerating the development of new therapies for patients with acute and/or chronic pain. MUSC has numerous resources and extensive experience with pain assessment, outcomes tracking, and clinical trial protocol development. The leadership of the MUSC-Hub has extensive experience and expertise conducting high quality multi-site and single-site phase-II clinical trials for pain, clinical trial network participation and administration, research resource development and oversight, and collaborative team science background. The MUSC-Hub and spoke network has access to a vast number of patients with a wide variety of well- phenotyped pain conditions. Different spokes have expertise and experience with different pain populations, and the overall volume of patients with chronic and acute pain within the MUSC-Hub and spoke network is extensive, affording us the ability to quickly recruit and enroll participants in a wide variety of clinical and research settings across the state. Through this program, we aim to form multidisciplinary clinical trial teams with close connections to physicians who are clinical and research experts providing care to patients with pain in the fields of primary care, orthopedics, neurology, anesthesiology, rheumatology, surgery, pediatrics, obstetrics/gynecology, addiction sciences, pain psychology, pain rehabilitation and abdominal pain. We will develop a system to rapidly and flexibly engage a number of spokes and sub-spokes in phase-II clinical trials by leveraging resources of our CTSA and NIDA-CTN programs, demonstrate efficiency of the MUSC-Hub system by participating in at least 2 network trials per year, supporting recruitment of at least 100 well- phenotyped subjects with specific pain conditions into concurrent phase 2 trials, and contribute to EPPIC-Net by serving on steering committees, proposing trials, and providing expertise in clinical trial proposal development.