Notice of Intent to Publish a Funding Opportunity Announcement for Cardiothoracic Surgical Trials Network Renewal - CCC (U10 - Clinical Trials Required)

Notice Number: NOT-HL-18-588

Key Dates
Release Date: February 12, 2018
Estimated Publication Date of Announcement: 05/15/2018
First Estimated Application Due Date: 07/17/2018
Earliest Estimated Award Date: 03/15/2019
Earliest Estimated Start Date: 03/15/2019

Related Announcements
None

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The National Heart, Lung, and Blood Institute intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications from qualified institutions willing to participate with NHLBI in the Cardiothoracic Surgical Trials Network (CTSN) as Linked Clinical Research Centers (LCRCs).   

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

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

This FOA plan to utilize the UM1 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into the area of Cardiac Surgery to begin to consider applying for this new FOA.

The LCRCs will: (1) conduct collaborative randomized controlled trials (RCTs) and studies that evaluate cross specialty team-based care, interventions and novel therapies in the context of cardiac surgery but with broader relevance to cardiology and neurology; (2) utilize these findings to improve patient outcomes, and influence clinical practice, with benefits that are translatable to the general population; (3) conduct implementation research alongside RCTs to understand the best strategies for optimal uptake and sustainability and to bolster translation in areas of high disease burden; and (4) foster the next generation of clinical and implementation researchers.
 
To achieve budget efficiencies, while at the same time enhancing the output and scope of the enterprise, the CTSN infrastructure will be slightly changed to include a new clinical research paradigm of paring experienced academic cardiac surgical clinical research centers with currently less experienced academic clinical research centers in high disease burden areas in the form of a Multi-PI grant application, the LCRCs. A total of 5 LCRCs are proposed with the awards made to high quality established academic cardiothoracic surgery programs with a track record of successful participation in RCTs that will incorporate a second academic cardiac surgical site with less clinical research experience.  Less experienced academic cardiac surgical sites should show fewer than 3 RCT trials conducted per year in cardiac surgery and less than $3 Million in NIH total grant funding to the institution in 2017. The less experienced academic cardiac surgical site should be one that would benefit from research mentoring and a collaborative clinical research opportunity, and is located in a high cardiovascular disease-burdened part of the country to build capacity in this area. A high cardiovascular disease burden area is broadly defined as an area or region of the United States or Canada that has a preponderance of cardiovascular disease including hypertension, obesity, diabetes, and stroke, or some other unique disease burden characteristic. These areas might include the geographic regions incorporating the Mississippi Delta, Appalachia, Stroke Belt (South East United States, Stroke Buckle (coastal plains areas of the Carolinas and Georgia), rural or inner-city locales, or involve predominantly minority or low SES populations. 
 
This enhanced platform will be further used to develop the next generation of clinical trialists and implementation researchers. Each LCRC application will also include a clinical and implementation research skills program. These skills programs will be encouraged to include underrepresented minorities to address needed diversity within the cardiac surgical clinical research workforce with the potential to transition into research leadership roles. The clinical and implementation research scholars will be developed side-by side and interact to expand skills and knowledge that can then be transported to academic and clinical programs when the Scholars complete their skills development.
 
Applications from the NHLBI-funded Core Clinical Centers (CCCs) will be evaluated in addition to applications from institutions not presently in the CTSN, with the requirement of the described site linkage and inclusion of a Clinical and Implementation Research Skills Program.

Funding Information


Estimated Total Funding

$3,200,000

Expected Number of Awards

5

Estimated Award Ceiling

$400,000

Primary CFDA Numbers

93.837, 93.840

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)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization

Inquiries

Please direct all inquiries to:

Marissa A. Miller, DVM, MPH
National Heart, Lung, and Blood Institute (NHLBI)
301-594-1542
Millerma2@nhlbi.nih.gov