Specialized Clinical Center at MGH for the Early Phase Pain Investigation Clinical Network

Massachusetts General Hospital, Boston MA

Investigators

Abstract

While acute pain treatment has been successful, chronic pain remains difficult to manage. New advances in chronic pain treatment are urgently needed. It is timely and insightful that NIH launches a program to establish an Early Phase Pain Investigation Clinical Network (EPPIC-Net) to serve as a cornerstone of the NIH?s Helping to End Addiction Long-term (HEAL) Initiative. In response to RFA-NS-19-036, we are applying for Specialized Clinical Center at MGH for the EPPIC-Net (MGH-Hub). This proposed Hub will utilize two well established collaborative entities in both patient care and clinical research at the Massachusetts General Hospital (MGH): 1) MGH Division of Pain Medicine and 2) MGH Center for Translational Pain Research. This Hub-spoke network will include four core spokes consisting of both academic centers and community healthcare organizations (Massachusetts General Hospital, Brigham Women?s Hospital, Beth Israel Deaconess Medical Center, and Boston Pain Care), as well as several on- demand spokes (spokes that can be recruited when needed) based on special requirements of phase II trials and research studies. Besides the Hub PI, there are committed Hub members who are clinician- scientists from a variety of medical specialties in nearly every aspect of chronic pain management and clinical trial expertise. There are also affiliated Hub members who will participate in clinical trials or biomarker validation studies if special expertise and technical skills (e.g., biospecimen collection, neuroimaging, quantitative sensory testing, EEG) are required but are not available from the committed Hub members. This Hub-spoke network at MGH will have access to a large pool of chronic pain patients from both metropolitan and rural areas, including back pain, arthritic pain, neuropathic pain, myofascial pain, headaches, and abdominal/pelvic pain. There is strong institutional support for the Hub, including MGH Research Institute, MGH Division of Clinical Research, Partners IT team, Institutional Research Board (IRB), institutional contract/agreement licensing office, and MGH office of Research Compliance. The responsibilities of this Hub-spoke network will include a) coordinating phase II trials/clinical biomarker validation studies; b) recruiting well-phenotyped study subjects in a timely manner; c) collecting, storing and transferring clinical and targeted outcome data tailored to meet the needs of each clinical trial/study; and d) maintaining communications within and outside the Hub, including the CCC and DCC of the NIH EPPIC-Net. We anticipate that this Hub-spoke network at MGH will serve as a reliable and productive specialized clinical center for phase II trials and clinical studies (e.g., biomarker validation studies) sponsored by the NIH EPPIC-Net. Investigators of this academic Hub-spoke network can also serve as valuable advisors and clinical consultants for the EPPIC-Net on a) phenotyping pain conditions, b) designing clinical trials/studies, and c) managing clinical trial-related side effects and complications.