Notice Number: NOT-NS-19-075
Key Dates
Release Date: September 11, 2019
Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
Purpose
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. 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 was identified as a high priority. In response NIH is establishing the Early Phase Pain Investigation Clinical Network (EPPIC-Net). The mission of EPPIC-Net is to improve the treatment of acute and chronic pain and reduce reliance on opioids. This will be accomplished by accelerating the early phase testing of non-addictive pharmacologic and device strategies for alleviating pain submitted by industry and academic investigators.
EPPIC-Net will lower the burden of early phase clinical testing and provide strong evidence to guide decisions for later phase trials for therapeutics for pain indications. In a continually learning network, EPPIC-Net researchers will provide needed knowledge of pain conditions, biomarkers, and innovative means of testing therapies to the research community with the singular goal of accelerating the process of making effective therapies for pain available to the public and reducing the reliance on opioids.
The research infrastructure for EPPIC-Net, established through previously published funding opportunities (RFA-NS-19-023, RFA-NS-19-024, RFA-NS-19-025, RFA-NS-19-036) is composed of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and Specialized Clinical Sites across the USA. These Centers and Sites will help EPPIC-Net
- Develop and test innovative clinical trial paradigms to establish best means of testing pain therapies.
- Establish well-characterized patient cohorts with specific pain conditions and outcome measures of utility for phase 2 trials.
- Continuously learn from experience to engineer ever-improving early phase testing of new pain therapies.
Please note that there is no funding provided to the asset holders applying to have their therapeutics studied within EPPIC-Net. Successful asset holders obtain access to EPPIC-Net for study of their therapeutics. NIH Other Transaction funds to conduct the study are awarded to the EPPIC-Net CCC, which administers the funds to other EPPIC-Net research components.
The HEAL Initiative, including EPPIC-Net, is now reaching out to industry and academia with potential phase 2-ready non-addictive pain therapeutics that might be tested in EPPIC-Net. Additional information and the Research Opportunity Announcement (ROA) OTA-29-008 can be found on the EPPIC-Net website https://www.ninds.nih.gov/Current-Research/Trans-Agency-Activities/NINDS-Role-HEAL-Initiative/NINDS-Role-HEAL-Initiative-EPPIC.
EPPIC-Net is soliciting assets to:
- Test new treatments for specific pain conditions in early phase trials (focused on phase 2) using therapeutic candidates (such as drug, biologicals, or device “assets”) with Go/No-Go criteria that inform decisions to move toward Phase 3 trials.
- Test the assets in phase 2 trials that help establish that a specific therapeutic pathway holds promise for a next generation device, small molecule or biologic.
- Use to validate biomarkers for utility in tests of target engagement or proof-of-principle that could be used to enable and accelerate discovery, development, and approval of new, non-addictive pain therapies.
Application Process for Clinical Trials in EPPIC-Net
Application submission and review: Applicants with a potential pain therapeutic should submit the EPPIC-Net preliminary application that provides information about their drug or device asset, the target condition or population, available preclinical or early phase clinical trial data and proposed study design.
The application form and information packet can be found at https://www.ninds.nih.gov/Current-Research/Trans-Agency-Activities/NINDS-Role-HEAL-Initiative/NINDS-Role-HEAL-Initiative-EPPIC. EPPIC-Net will open for applications on September 3, 2019.
An objective review process will be used to select highly meritorious applications. Those applicants will then be invited to work with an NIH contractor to develop a more detailed “dossier” with information about the asset and proposed clinical trial. After dossier review, selected applicants will proceed to work with the EPPIC-Net CCC, DCC, and Specialized Clinical Sites to develop a clinical protocol. Clinical protocols will be submitted by the CCC for final stage review. Highly meritorious protocols will be selected for implementation of the asset clinical trial within EPPIC-Net, with trial funding provided to and managed by the CCC for distribution to the Clinical Sites.
Inquiries
Please direct all inquiries to:
Barbara I. Karp, MD
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-0150
Email: barbara.karp@nih.gov
Rebecca Hommer, MD
National Institute of Neurological Disorders and Stroke
Telephone: 301-827-2257
Email: rebecca.hommer@nih.gov
and Human Services (HHS)
