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Early Phase Pain Investigation Clinical Network (EPPIC-Net)
Early Phase Pain Investigation Clinical Network (EPPIC-Net) seeks to enhance the treatment of acute and chronic pain and reduce reliance on opioids by accelerating early phase clinical trials of non-addictive pain therapeutics, including drugs and devices.
- Test new pain treatments (e.g. small molecules, biologics and/or devices) with Go/No-Go criteria in early-stage trials to move toward efficacy trials for regulatory approval.
- Provide proof-of-concept clinical testing of potential biomarkers and new treatments, to help identify specific pathways or mechanisms that holds promise for future therapeutic development.
- Validate biomarkers for utility in assessing target engagement or pain outcomes that could be used to accelerate development of new, non-addictive pain therapies.
- Develop and test innovative clinical trial paradigms to evaluate pain therapies.
- Establish well-characterized patient cohorts with specific pain conditions and clearly-defined outcome measures for early-stage trials.
- Continuously learn from experience to engineer adaptive, ever-improving early phase testing of new pain therapies.
EPPIC-Net will support clinical trials of:
- Investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain.
- Deeply phenotyped patients with pain conditions of high unmet need.
- Drugs or devices with a high potential to move to industry-funded phase 3 efficacy trials, should the early phase study achieve the prespecified endpoints.
EPPIC-Net will interface with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Back Pain Consortium (BACPAC) to study response of mechanistic subtypes of back pain patients to specific interventions.
Supporting NIH Institutes and Centers
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Center for Complementary and Integrative Health (NCCIH)
- National Cancer Institute (NCI)
- National Eye Institute (NEI)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institute on Drug Abuse (NIDA)
- National Institute of Dental and Craniofacial Research (NIDCR)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institute of Nursing Research (NINR)
The application and review process for EPPIC-Net has 3 stages.
Stage 1: The applicant completes the brief preliminary application and submits it via eRA Commons. Following independent review, top-ranking applications will be selected to proceed to Stage 2. Open to all applicants.
Stage 2: The applicant works with an NIH contractor to prepare a dossier with detailed information on the asset, including drug pharmacology or device specifications. Following further independent review, top-ranking applications will be selected to proceed to Stage 3. By invitation only.
Stage 3: The applicant works with the EPPIC-Net CCC, in consultation with the EPPIC-Net DCC and appropriately-matched Clinical Research Sites to develop the clinical protocol. The clinical protocol undergoes a final independent review. Top-ranking protocols will be presented to the NINDS Council and HEAL Leadership, who will approve protocols for funding and study implementation within EPPIC-Net.
Successful applicants receive access to EPPIC-Net resources for developing and conducting a clinical trial for their asset; they do not receive funding.
- Preliminary Application Instructions
- Initial Asset Application
- ERA Instruction Guide for OTA Submission
Barbara I. Karp, MD
This page last reviewed on August 7, 2019