NOT-NS-18-058 The National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Clinical Coordinating Center (CCC) for a new Clinical Trials Network on Pain Research (CTNPR). The CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.
The network will be charged with testing novel, non-addictive treatments for patients suffering from acute or chronic pain conditions.
The CTNPR will harness multidisciplinary expertise in pain science and clinical research to collaboratively design and conduct Phase 2 multicenter clinical trials testing novel pain treatments. It will also perform validation studies of biomarkers with promise to inform target engagement or proof of principle in Phase 2 clinical trials. The CTNPR will develop deeply phenotyped cohorts with specific acute and chronic pain conditions in adults and children. The emphasis of the CTNPR will be on pain conditions of high unmet needs.
Interventions to be studied may include drugs, biologics, devices, natural products and surgical procedures. The CTNPR will be composed of one CCC, one Data Coordinating Center (DCC), and approximately 10 clinical centers (Hubs). The Hubs will be Centers of Excellence with physicians with pain expertise from neurology, anesthesiology, rheumatology, physical medicine, obstetrics/gynecology, pediatrics, orthopedics, gastroenterology, and other subspecialties providing care to patients with pain. Each Hub is envisioned as a regional medical center that will enroll patients along with its network of 2-10 satellite sites (Spokes).