Early Phase Pain Investigation Clinical Network (EPPIC-Net)

Early Phase Pain Investigation Clinical Network (EPPIC-Net)

PLEASE NOTE: EPPIC-NET IS OPEN TO APPLICATIONS - PLEASE USE ROA #OTA-19-008  (PDF, 180KB) TO SUBMIT YOUR APPLICATION IN eRA COMMONS

Applications will be accepted and reviewed on a rolling basis.  

PLEASE NOTE: The deadline for applications for the 2nd cycle is November 13, 2019. The deadline for the 3rd cycle is December 20, 2019.

Download the Preliminary Application Packet  (PDF, 3MB)

Download slides from the EPPIC-Net Application Webinar, August 23, 2019 (PDF, 7MB)

Download the Research Opportunity Announcement: ROA OTA-19-008  HEAL Initiative: EPPIC-Net Pain Research Asset Application (OT1) (PDF, 180KB)

View the EPPIC-Net webinar

The NIH HEAL Initiative

In April 2018, NIH launched the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. A major goal of the HEAL Initiative is to spur the development of effective, non-addictive treatments to reduce the burden of illness due to pain and to reduce risk of addiction. Over the past 2 years, NIH has gathered input from experts from the U.S. Food and Drug Administration (FDA), academia, and the private sector to identify key gaps and opportunities for the development of new treatments for pain. Through these consultations, NIH identified the need for a sophisticated clinical trial network to design and execute innovative early phase trials of promising non-addictive pain therapies in well-characterized patient cohorts with pain conditions of high unmet need. The Early-Phase Pain Investigation Clinical Network (EPPIC-Net), led by the NINDS, seeks to fill this need by establishing a clinical trials network for highly meritorious assets for the treatment of pain.

Through EPPIC Net, NIH aims to: 

  • Provide academic and industry investigators with expert infrastructure and support for early-phase clinical testing of pain therapeutics across populations and the lifespan
  • Reduce reliance on opioids by accelerating early-phase clinical trials of non-addictive pain therapeutics, including drugs and devices

Studies in EPPIC-Net will:

  • Test new, non-addictive pain therapeutics in early-stage trials of drugs, biologics, and devices, focused on Phase 2 clinical trials
  • Provide proof-of-concept testing and validation of potential biomarkers for utility in assessing target engagement or pain outcomes
  • Develop and test innovative clinical trial paradigms to engineer adaptive, ever-improving early-phase testing of new pain therapies
  • Establish multiple well-characterized cohorts of different pain conditions for clinical trials

For assets submitted to EPPIC-Net, NIH will prioritize applications for:

  • Drugs or biologics with an existing IND or devices with an existing IDE
  • Drugs, biologics or devices with potential to treat pain conditions of high unmet need
  • Drugs, biologics or devices that have high potential to move to industry-funded phase 3 efficacy trials and into clinical use

The EPPIC-Net infrastructure

The EPPIC-Net Infrastructure, established through a competitive grant process, includes:

The Clinical Coordinating Center (CCC) provides protocol development, overall trial management, site and investigator training, and interface with IRB.

The Data Coordinating Center (DCC) provides data management and analysis expertise and tools, quality assurance, and centralized data and biorepositories.

Clinical Research Sites (Hubs) provide clinical researchers with pain expertise, focused patient populations, and wide outreach into pain communities, and conduct the research procedures.

EPPIC-Net APPLICATION PROCESS

The application and review process for EPPIC-Net has 3 stages.

Stage 1: The applicant completes the brief preliminary application which can be found in the “EPPIC-Net Preliminary Application Packet” (PDF, 3MB) and submits it via eRA Commons. Following independent review, top-ranking applications will be selected to proceed to Stage 2.

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.

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.

IMPORTANT NOTES:

  • Stage 1 application is open to all; Stages 2 and 3 are by invitation only.
  • No funding is associated with application stages 1 and 2.
  • Successful asset applicants receive access to EPPIC-Net resources for conduct of the clinical trial for their asset. Asset applicants do not receive funding. Funding for selected clinical protocols is provided to the EPPIC-Net infrastructure components for conduct of the trial.
  • Download slides from the EPPIC-Net Application Webinar, August 23, 2019 (PDF, 7MB)
  • View the Webinar

Intellectual property and products studied within EPPIC-Net remain the property of the asset owner

How to apply to EPPIC-Net

  1. Register in eRA Commons using ASSIST. The ROA NUMBER to be used in eRA Commons is OTA-19-008.
  2. Complete the EPPIC-Net preliminary application pdf form (PDF, 3MB).
  3. Submit the preliminary application to EPPIC-Net via eRA Commons.

APPLICANTS WILL RECEIVE A SUBMISSION RECEIPT.

APPLICANTS WILL RECEIVE NOTIFICATION OF DECISIONS ONCE INDEPENDENT REVIEW IS COMPLETE.

Download the Preliminary Application Packet (PDF, 3MB)