Early Phase Pain Investigation Clinical Network (EPPIC-Net)

Overview

The Research Need

The 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 treatments for pain. 

About the Program

EPPIC-Net has the capacity to quickly and efficiently conduct many simultaneous multisite studies. The network will conduct studies on a variety of treatments, including drugs and devices, as well as studies to better understand pain.

EPPIC-Net will:

  • Test new pain treatments (e.g., small molecules, biologics, 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 hold 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 supports clinical trials focused on:

  • 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 strong potential to move to industry-funded Phase 3 efficacy trials, should the early-phase study achieve the prespecified endpoints

EPPIC-Net interfaces with the National Institute of Arthritis and Musculoskeletal and Skin Diseases’ Back Pain Consortium (BACPAC) to study how people with different types of back pain respond to specific interventions.

Learn more about how the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM is involved in BACPAC.

Program Details

Through the NIH HEAL Initiative, NIH has awarded 14 grants to form EPPIC-Net. The awards, totaling approximately $51.1 million, come from multiple NIH Institutes and Centers.

Funding for clinical trials conducted within EPPIC-Net derives from NIH’s Other Transaction Authority, which differs from grants, contracts, and cooperative agreements. Intellectual property and products studied within EPPIC-Net remain the property of the owners of those assets. 

The network includes 12 Specialized Clinical Centers, each with multiple sites. It also includes two centers that will provide supportive infrastructure.

  • The Specialized Clinical Centers are connected with a large number of pain patients who can be recruited for participation in trials, including children, people over 65, veterans, patients involved with different subspecialties (e.g., dentistry, gynecology, oncology, urology), and people of various races and ethnicities. EPPIC-Net will work with academic and industry partners to conduct the trials.
  • The Clinical Coordinating Center (CCC) will provide scientific leadership for the design and conduct of clinical studies. The CCC will also provide support on methods, organization, and logistics for the multicenter trials conducted within EPPIC-Net.
  • The Data Coordinating Center (DCC) will manage data and biospecimens from the trials conducted in EPPIC-Net and other parts of the NIH HEAL Initiative’s pain research program. The DCC will make these data and biospecimens available to pain researchers. It will also provide expertise and leadership on statistical design and analysis of studies conducted within EPPIC-Net.

Research Examples

The awards support a network to advance new treatments for pain by conducting early-phase clinical trials with adults and children. These awards are not for individual trials. Instead, NIH is awarding 12 research hubs that will serve as regional coordinating centers, creating the capacity to run many clinical trials across multiple sites.

Research Institutions

  • Duke University – North Carolina
  • Icahn School of Medicine at Mount Sinai – New York
  • Massachusetts General Hospital – Massachusetts
  • Medical College of Wisconsin – Wisconsin
  • Medical University of South Carolina – South Carolina
  • New York University School of Medicine – New York
  • University of California, San Diego – California
  • University of Florida – Florida
  • University of Pennsylvania – Pennsylvania
  • University of Pittsburgh at Pittsburgh – Pennsylvania
  • University of Rochester – New York
  • University of Washington – Washington

Clinical Coordinating Center

  • Massachusetts General Hospital – Massachusetts

Data Coordinating Center

  • New York University School of Medicine – New York

Funded Projects

2019
California Clinical and Translational Pain Research Consortium
Sep 25, 2019
2019
Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network
Sep 25, 2019
2019
Duke Pain Early-phase Research Clinical Center (PERC)
Sep 25, 2019
2019
Early Phase Pain Investigation Clinical Network: Greater New York Clinical Center
Sep 25, 2019
2019
UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center
Sep 25, 2019

Open Funding Opportunities

2019
HEAL/NINDS Early Phase Pain Investigation Clinical Network (EPPIC-Net): Opening to applications for non-addictive pain therapeutics
Sep 11, 2019
2019
Notice of Information: Clinical Trials that Explore Non-Addictive Therapeutics for Pain Conditions under the Early Phase Pain Investigation Clinical Network (EPPIC-Net)
Sep 25, 2019

Closed Funding Opportunities

2019
HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
Sep 25, 2019

Application Process

The application and review process for EPPIC-Net has three 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 NIH HEAL Initiative 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.

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