NOT-NS-18-069 The National Institute for Neurological Disorders and Stroke intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Clinical Trials Network on Pain Research (CTNPR). The network will be charged with executing trials of high impact for the treatment of patients with acute and chronic pain. The CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.
The network will be composed of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and ten Regional Clinical Centers together with their linked clinical sites.
The purpose of this notice is to allow potential applicants sufficient time to develop meaningful collaborations and projects for the clinical centers ("Hubs") CTNPR. The CTNPR will enable exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain. These trials may validate biomarkers, provide proof of mechanism, and otherwise contribute to the justification for proceeding or not proceeding to a future Phase 3 trial (e.g., informing go/n-go decisions). The specific pain conditions will include well-defined ones with high unmet needs and more common, chronic neuropathic, inflammatory or nociceptive pain disorders in adult and pediatric populations. The network will focus on multi-site Phase 2 trials. The network will also implement clinical studies for biomarker discovery and validation, and will store biomarker data and samples for future biomarker discovery. It is anticipated that the CTNPR will be able to run as many as five Phase 2 trials concurrently in addition to biomarker validation studies.