Notice of Intent to Publish a Funding Opportunity Announcement for Early Liver Transplantation Cohort Study (U10 - Clinical Trial Optional)

Notice Number: NOT-AA-19-025

Key Dates

Release Date: September 10, 2019
Estimated Publication Date of Funding Opportunity Announcement: December 01, 2019
First Estimated Application Due Date: February 01, 2020
Earliest Estimated Award Date: September 01, 2020
Earliest Estimated Start Date: September 01, 2020

Related Announcements
None

Issued by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for collaborative research projects (U10) to conduct observational clinical studies in patients with severe forms of alcohol-associated liver disease (AALD) undergoing Early Liver Transplantation (ELT).

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and competitive research programs.

The FOA is expected to be published in Fall 2019 with an expected application due date in Winter 2020.

This FOA will utilize the NIH cooperative agreement award mechanism U10.

Research Initiative Details

This Notice encourages investigators with expertise and insights in the area of comprehensive, state-of-the-art treatment programs at Liver Transplant Centers in the United States to begin to consider applying for this new FOA.

In addition, collaborative investigations combining expertise in hepatology, liver transplant surgery, behavior, addiction treatment, ethics, physical therapy, psychiatry, psychosociology should also begin considering applying for this application.

This funding opportunity will support a cooperative program of investigators to conduct an ELT cohort study in patients with severe forms of alcohol-associated liver disease and short pre-transplant period of abstinence (i.e., before achieving 6 months of sobriety). The cooperative program will include a Study Chair, a Data Coordinating Center, and participating transplant centers. The purpose is to document the long-term outcome and ascertain factors that influence the success of ELT including strategies to manage addiction.

Among the areas of research encouraged in this initiative are studies that focus on evaluation of risk/benefit of ELT, strategies to reduce pre- and post-operative risk, understanding the impact and management of comorbidities, increased cancer and alcohol relapse risk, as well as healthcare disparities, utilization and costs. Research supported by this initiative is expected to yield evidence that will inform selection, management, and long-term health and behavioral outcomes in ELT patients.

The FOA will utilize the U10 activity code to support a multisite prospective observational study involving 3 or more highly integrated research sites that share study protocols and are organized as a collaborative unit in order to increase sample size, accelerate recruitment, and increase sample diversity and representation. The U10 application will comprise all component applications of the study including the Study Chair application and Data Coordinating Center application. Applications from participating transplant centers will be included as subcontracts to the Study Chair application. This cooperative program model will provide a mechanism for fostering interdisciplinary cooperation that will establish and maintain the infrastructure required to accrue and follow sufficient numbers of patients undergoing ELT to provide generalizable data from adequately powered studies.

Applications are required to address research questions of significant complexity and impact that cannot be accomplished using individual or MPI R01s. The following types of studies are not intended to be supported by this FOA and applications proposing such activities will be deemed non-responsive and returned without review: (1) Single-site studies; (2) Animal models studies; (3) Retrospective studies whether multi- or single-site; (4) Phase I and Phase II clinical trials.

Funding Information

Estimated Total Funding TBD
Expected Number of Awards 0-2
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.273

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)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County 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
Eligible Agencies of the Federal Government
Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Abraham P. Bautista, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
301-443-9737
bautista@mail.nih.gov