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.