RFA-DK-20-003: Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required)
Internal Deadline: September 18, 2020, noon PT.
LOI: November 1, 2020
External Deadline: December 1, 2020
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: It is expected that up to 11 awards will be supported in FY 2021 in total under these two RFAs. See more info below.
Anticipated Amount: The NIDDK intends to commit $6 million in FY 2021 to support two related approaches to the establishment of the Liver Cirrhosis Network as embodied in RFA-DK-20-003 and RFA-DK-20-004.
Process for Limited Submissions: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://research.usc.edu/usc-grants/.
Materials to submit include:
(1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
(2) CV – (5 pages maximum)
Who May Serve as PI: For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
Purpose: The Liver Cirrhosis Network will be administered under a Cooperative Agreement and be composed of Clinical Centers (CC), a single Scientific Data Coordination Center (SDCC), and the NIDDK and other components of the NIH as deemed appropriate by the NIDDK. The Liver Cirrhosis Network will be governed by a Steering Committee composed of investigators from each of the Clinical Centers, the Scientific Data Coordination Center, and the NIDDK and other components of the NIH as deemed appropriate by the NIDDK.
To accelerate the purpose of this FOA through the establishment of the Liver Cirrhosis Network, the NIDDK is proposing two broad approaches to be undertaken. First is the establishment of a Longitudinal Cohort of patients with cirrhosis. Second is the development and implementation of an intervention trial using an HMG-coenzyme A reductase inhibitor (“statin”). All studies undertaken by the Liver Cirrhosis Network will be performed with adult subjects. The findings and results emanating from these two approaches should advance the understanding about the pathophysiological mechanistic aspects of liver fibrosis from both pro- and anti-fibrotic processes; improve the assessment of clinical risk factors associated with advancement or recession of liver fibrosis; an opportunity to assess noninvasive measures of liver fibrosis and cirrhosis in conjunction with clinical measures; and determine the safety and efficacy of statin therapy in preventing disease progression and adverse clinical outcomes of cirrhosis.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.