Notice of Intent to Publish a Funding Opportunity Announcement for Clinical Centers for the Clinical Trials Network on Pain Research (CTNPR) (U24 Clinical Trial Not Allowed)

Notice Number: NOT-NS-18-069

Key Dates

Release Date:June 14, 2018
Estimated Publication Date of Funding Opportunity Announcement: 07/16/2018
First Estimated Application Due Date: 09/14/2018
Earliest Estimated Award Date: 12/04/2018
Earliest Estimated Start Date: 12/04/2018

Related Announcements
NOT-NS-18-057
NOT-NS-18-058

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

Purpose

The National Institute for Neurological Disorders and Stroke intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Clinical Trials Network on Pain Research (CTNPR). The network will be charged with executing trials of high impact for the treatment of patients with acute and chronic pain. The CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.

The network will be composed of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and ten Regional Clinical Centers together with their linked clinical sites.

The purpose of this notice is to allow potential applicants sufficient time to develop meaningful collaborations and projects for the clinical centers ("Hubs") CTNPR.  The CTNPR will enable exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain.  These trials may validate biomarkers, provide proof of mechanism, and otherwise contribute to the justification for proceeding or not proceeding to a future Phase 3 trial (e.g., informing go/n-go decisions).  The specific pain conditions will include well-defined ones with high unmet needs and more common, chronic neuropathic, inflammatory or nociceptive pain disorders in adult and pediatric populations. The network will focus on multi-site Phase 2 trials.  The network will also implement clinical studies for biomarker discovery and validation, and will store biomarker data and samples for future biomarker discovery.  It is anticipated that the CTNPR will be able to run as many as five Phase 2 trials concurrently in addition to biomarker validation studies.

The CTNPR will consist of one Clinical Coordinating Center (CCC), one Data Coordinating (DCC), and 10 clinical centers (Hubs).   A Hub will be a center of excellence with physician expertise in neurology, anesthesiology, rheumatology, obstetrics/gynecology, pediatrics, orthopedics, physical medicine, gastroenterology, or other subspecialties providing care to patients with pain.  Each Hub is envisioned as a regional medical center that will enroll patients along with its network of 2-10 satellite sites (Spokes). A Hub will additionally provide scientific leadership and administrative oversight to its multiple satellite sites ("Spokes"). 

This notice solicits applications for the CTNPR Clinical Centers. Separate notices have been issued for the Clinical Coordinating Center and the Data Coordinating Center (NOT-NS-18-058 and NOT-NS-18-057).

Interventions for trials within the CTNPR will be solicited from the national scientific community.  The CTNPR will design and execute trials with investigational drugs, devices or biologics provided by companies and academics.

The FOA is expected to be published in July 2018 with an expected application due date in September 2018.

This FOA will utilize the U24 activity code.

Research Initiative Details

Each Hub must have a flexible network of Spokes.  The principal function of the Spokes is to provide access to a larger patient population for trial enrollment.  Spokes also increase access to patients with a particular disease or syndrome, to patients from underserved communities, or complement the Hub by providing access to specific research or clinical expertise.  For each clinical trial, the Hub would be expected to construct a network of 2-10 Spokes specifically tailored to the needs of that particular trial. Since the requirements of each clinical trial will be somewhat different, 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 demonstrate the ability to attract Spokes, the applicant is requested to identify in the grant submission five Spokes committed to participation in at least one clinical trial.   Since these five Spokes are unlikely to meet all possible clinical trial requirements, the Hub may need to have plans and mechanisms for recruiting and adding other Spokes, when needed.

As mentioned in NOT-OD-18-181, any for-profit recipient of funds shall be subject to a matching requirement of funds or documented in-kind contributions of not less than 50 percent of the total funds awarded to such entity.

Funding Information

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

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:

Jeremy Brown MD

National Institute of Neurological Disorders and Stroke (NINDS)

301-827-8375
jeremy.brown@nih.gov