Notice of Intent to Publish a Funding Opportunity Announcement for Clinical Trials Network on Pain - Data Coordinating Center (U24 Clinical Trial Not Allowed)

Notice Number: NOT-NS-18-057

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-18-058
NOT-NS-18-069

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

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Data Coordinating Center (DCC) for a new Clinical Trials Network on Pain Research (CTNPR). This CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.

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 and provide the data required for designing a future Phase 3 trial.  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 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. Further, it is anticipated that a number of the investigational drugs, biologics, and devices tested may come from private companies or academics.   

The DCC will have responsibility for web-based data collection, data management and quality assurance, statistical design and analysis, and reporting to the Data and Safety Monitoring Boards and regulatory and oversight groups.  More importantly, the DCC will be expected to provide innovative statistical leadership to the CTNPR with the goal of accelerating the discovery and evaluation of treatments for pain. The DCC will also house a data repository and biosample repository. It is envisioned that the DCC will also serve as the convener of an Expert Panel that consists of objective subject matter experts with experience in developing therapeutics. This Expert Panel would serve as the liaison to private companies who may contribute therapeutics to the CTNPR for testing. These analyses will be submitted to an NIH Scientific Review committee for prioritization.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The FOA is expected to be published in Summer 2018 with an expected application due date in Fall 2018.
This FOA will utilize the U24 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise in biostatistics and data management for multicenter clinical trials to begin to consider applying for this new FOA.  Experience with novel, efficient study designs including response-adaptive randomization and basket or platform designs, and designs using biomarkers as endpoints, will be especially important.  Expertise in risk-based site monitoring will be valuable, as will experience in the use of digital/mobile/sensor technologies and web-based systems to facilitate data collection (including data collection in a continual, contextual, real-world setting rather than through a traditional milestone-based approach) and to enhance protocol adherence.

It is envisioned that the network would be scaled to run five concurrent Phase 2 trials over this 5-year project, in addition to biomarker validation studies.

Applications for the Clinical Coordinating Center (CCC) will be solicited in a separate FOA issued at the same time as the DCC FOA.  Awards for a CCC and a DCC will not be made to the same PD/PI or institution to ensure that data analyses are performed independently. Funding for individual studies will be provided through individual study grants   Applications for Hubs and for the clinical trials and studies themselves will be solicited in future FOAs.

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 1
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)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)

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