Notice Number: NOT-NS-19-043

Key Dates
Release Date: March 13, 2019

RFA-NS-19-023
RFA-NS-19-024
RFA-NS-19-025
NOT-NS-19-075

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 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)

EPPIC-Net seeks to improve the treatment of acute and chronic pain and reduce the reliance on opioids by accelerating the early phase testing of non-addictive pharmacologic and device strategies from industry and academic investigators for alleviating pain.

NIH with broad input from the appropriate NIH Advisory Council will reach out to industry and academia for interventions to be tested in EPPIC-Net. This will lower the burden of early phase clinical testing and provide strong evidence to guide decisions on proceeding to later phase trials for a pain indication. In a continually learning network, EPPIC-Net researchers will provide needed knowledge of clinical populations, 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 goals of the clinical trials in EPPIC-Net are to:

1. Test new treatments in early-stage trials using therapeutic candidates ( assets encompassing small molecules, biologics, devices) with Go/No-Go criteria that inform decisions to move toward efficacy trials for regulatory approval.
2. Test new treatments in early-stage trials using assets that help establish that a specific therapeutic pathway holds promise for a next generation device, small molecule or biologic.
3. 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.
4. Develop and test innovative clinical trial paradigms to establish best means of testing a variety of pain therapies.
5. Establish well-characterized patient cohorts with specific pain conditions and outcome measures of utility in early-stage trials.
6. Continuously learn from experience to engineer ever-improved early phase testing of new pain therapies over time.

The scientific focus of the clinical trials in EPPIC-Net is open to all pain conditions.

The research infrastructure for EPPIC-Net will be established through previously published funding opportunities (RFA-NS-19-023, RFA-NS-19-024, RFA-NS-19-025) and will be composed of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and regional Clinical Hubs with linked clinical sites.

Application Process for Clinical Trials in EPPIC-Net

Stage 1. Asset submission and review: Applicants will submit preliminary information about their drug or device ( asset ), the target condition or population, available preclinical or early phase clinical drug/device data and proposed study design through a template. Interested applicants can visit www.ninds.nih.gov/EPPICNet for more information and to be alerted when asset application templates are made available.

An objective review process will be used to select high ranking applications. These high-ranking applications will proceed to the next stage.

Stage 2. Development and review of a detailed dossier : Successful applicants from stage 1 will be invited to develop a more detailed proposal ( dossier ) that will be submitted for a second objective review process. These high-ranking proposals will proceed to the next stage.

Stage 3. Protocol development, research site selection, and implementation: Successful applicants will work with the investigators from EPPIC-Net to develop a tailored clinical trial protocol, which will receive a final round of objective review. These protocols will be subject to final approval by NIH and then funded through the Other Transaction (OT) mechanism. The use of Other Transaction Authority will enable NIH to rapidly initiate clinical trials for EPPIC-Net and adapt as new knowledge and technologies emerge.

Inquiries

Please direct all inquiries to:

Barbara I. Karp, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-0150
E-mail: [email protected]