Notice of Intent to Publish the Reissuance of "RFA-NS-19-025" "HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)"

Notice Number: NOT-NS-19-051

Key Dates

Release Date:April 11, 2019
Estimated Publication Date of Funding Opportunity Announcement: April 22, 2019
First Estimated Application Due Date: June 03, 2019
Earliest Estimated Award Date: November 01, 2019
Earliest Estimated Start Date: December 01, 2019

Related Announcements
RFA-NS-19-025

Issued by
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Institute for Neurological Disorders and Stroke intends to re-issue a Funding Opportunity Announcement (FOA) to solicit additional applications for regional clinical centers with associated clinical research sites for the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will be charged with executing early phase trials of high impact for the treatment of patients with acute and chronic pain. The regional clinical centers ("hubs" and their linked clinical research sites ("spokes") will conduct clinical trials in concert with a network Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC). Approximately ten regional clinical center Hubs are anticipated to be funded. The purpose of this notice is to allow potential Hub applicants sufficient time to develop meaningful plans and collaborations with their linked clinical center spokes in support of their application.

EPPIC-Net is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative. EPPIC-Net will enable exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of specific types of pain. Thesetrials may validate biomarkers, provide proof of concept, and otherwise contribute to the justification for proceeding or not proceeding to a futurePhase 3 trial (e.g., informing go/no-go decisions). Interventions for trials within EPPIC-Net will be solicited from the national and international scientific community. Interventions (e.g. investigational drugs, devices or biologics) studied within EPPIC-Net may be provided by companies or academic institutions. The populations to be studied include those with well-defined pain conditions and with high unmet needs, for example chronic neuropathic, inflammatory or nociceptive pain disorders in adult and pediatric populations. EPPIC-Net will focus on Phase 2 trials and is anticipated to be able to run as many as five Phase 2 trials concurrently, in addition to biomarker validation studies. The EPPIC-Net infrastructure will also include a repository for HEAL initiative data and samples to facilitate future research and discovery.

TheEPPIC-Net Hubs will work with the EPPIC-Net CCC, DCC and other hubs selected for particular studies. Each Hub is envisioned as a regional medical center that is a center of excellence encompassing medical expertise in neurology, anesthesiology, rheumatology, obstetrics/gynecology, pediatrics, orthopedics, physical medicine, gastroenterology, and/or other subspecialties providing care to patients with pain. The Hub willenroll patients along with its network of 2-10 research spokes and will additionally provide scientific leadership and administrative oversight to its multiple spokes.

This notice informs clinical centers of excellence of the forthcoming solicitation for applications for EPPIC-Net hubs.

Research Initiative Details

Each Hub must have a flexible network of Spokes. The principal function of the Spokes is to provide access to a sufficiently large patient population to support trial enrollment. Spokes should be selected to increase access to patients with a particular pain disease or pain syndrome, to encompass patients from underserved communities, and/or to complement the Hub by providing access to specific research or clinical expertise. For each clinical trial, the Hub would be expected to assemble a network of 2-10 Spokes specifically tailored to the needs of that particular trial. Since the requirements of each clinical trial will vary, the identity and configuration of Spokes will be unique for each trial. Therefore, a Hub should have relationships with a number of potential Spokes and the ability to add Spokes as appropriate to the study. To demonstrate the ability to attract Spokes, the applicant is requested to identify, at the time of application, five Spokes committed to participation in at least one clinical trial.Since these five initial Spokes are unlikely to be able to meet all possible future clinical trial requirements, the Hub may need to incorporate a plan and mechanism for recruiting additional Spokes as needed.

Funding Information

Estimated Total Funding TBD
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.853

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Barbara I. Karp, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
301-496-0150
karpb@ninds.nih.gov