Notice of Intent to Publish a Funding Opportunity Announcement for Clinical Trials Network for Pain - Clinical Coordinating Center (U24 Clinical Trial Optional)

Notice Number: NOT-NS-18-058

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-18-069

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 Clinical Coordinating Center (CCC) for a new Clinical Trials Network on Pain Research (CTNPR).  The CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.

The network will be charged with testing novel, non-addictive treatments for patients suffering from acute or chronic pain conditions.

The CTNPR will harness multidisciplinary expertise in pain science and clinical research to collaboratively design and conduct Phase 2 multicenter clinical trials testing novel pain treatments. It will also perform validation studies of biomarkers with promise to inform target engagement or proof of principle in Phase 2 clinical trials.  The CTNPR will develop deeply phenotyped cohorts with specific acute and chronic pain conditions in adults and children. The emphasis of the CTNPR will be on pain conditions of high unmet needs.

Interventions to be studied may include drugs, biologics, devices, natural products and surgical procedures.  The CTNPR will be composed of one CCC, one Data Coordinating Center (DCC), and approximately 10 clinical centers (Hubs).  The Hubs will be Centers of Excellence with physicians with pain expertise from neurology, anesthesiology, rheumatology, physical medicine, obstetrics/gynecology, pediatrics, orthopedics, gastroenterology, and 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).   

The CCC and the leaders of the Clinical sites will play a critical role designing clinical trial protocols to be conducted in the CTNPR.  Interventions will be solicited from a variety of sources including pharmaceutical industry, medical device companies, and academics.  These will be prioritized by a separate NIH scientific review committee.  The most promising interventions will be assigned to the CCC and the CTNPR leadership who will work with outside investigators—including those from the HEAL Public-Private Partnership—to develop innovative Phase 2 clinical trial protocols to test the highest priority tailored interventions in patients with specific pain conditions.


The CCC will provide scientific and organizational leadership to the CTNPR.  The CCC is the administrative center of the CTNPR, with responsibilities for contracts with sites for performance of clinical trials and studies (master trial agreements with the clinical centers, other entities), planning budgets for proposed clinical trials, and disbursing payments to sites. The CCC leads and manages the key CTNPR governance committees.

The CCC has primary responsibility for identifying the central IRB.  The CCC is responsible for oversight of all aspects of trial enrollment and recruitment, from feasibility assessment, to planning, tracking and, if necessary, improvement plans.  The CCC also is responsible for quality assurance related to clinical trials and to the overall performance of the CTNPR. The CCC will collaborate closely with the DCC, the clinical research sites, and the clinical trial PDs/PIs with the goal of accelerating the discovery and evaluation of treatments for pain.

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 July 2018 with an expected application due date in September 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 appropriate expertise to begin to consider applying for this new FOA.

The PD/PI for the Clinical Coordinating Center (CCC) must be a clinical trials expert who has successfully coordinated and implemented multicenter clinical trials. Experience in neurology and pain clinical trials is especially relevant.  Since the CCC PD/PI is the chair of several CTNPR governance committees, it is important that he or she have sufficient time to attend and actively contribute to the committee meetings.

Members of the CCC research team might include:

  • Experienced study coordinators and/or project managers, potentially with areas of subspecialty such as recruitment or interactions with IRBs;  
  • Experienced financial coordinator or manager;
  • Site Support Manager or comparable staff for training of all Hubs, Spokes and ad hoc clinical sites;
  • Components of the central IRB, such as IRB chair, members, director; and
  • Liaisons to the IRB and clinical sites.

Applications for the 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. Industry partnerships will be encouraged.  Applications for Hubs and for the clinical trials and studies themselves will be solicited in future FOAs.

Investigators at the CCC institution may apply for a Hub award.  A CCC and a Hub at the same institution should be led by separate PDs/PIs to ensure that the CCC activities and the local Hub activities each receive full attention and to preserve needed firewalls.

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)
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)
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