Data & Analysis Core

ABSTRACT— Data and Analysis Core
The Program Project (PP) overarching goal is to reduce the burden of hepatocellular carcinoma (HCC)-related
mortality. We will achieve this goal by enhancing the understanding of contemporary risk factors (e.g.,
phenotypic, biochemical, and genetic markers of metabolic dysfunction) and preventive strategies (e.g.,
chemoprevention, surveillance) for rapidly increasing HCC related to metabolic (dysfunction) associated fatty
liver disease (MAFLD). The PP includes three Projects; two shared resource cores, the Data and Analysis
Core (DAC) and the Biospecimen and Biomarker Development Core (BBDC); and the Administrative Core, all
with the shared mission of stemming the rising tide of MAFLD-HCC.
Central to this PP is leveraging and expanding our multicity, ongoing prospective cohort of persons with MAFLD-
related cirrhosis, as well as a retrospective cohort identified in the national Department of Veterans Affairs (VA)
datasets. The aims of the three projects require rigorous implementation of well-designed protocols for
coordination and implementation of patient enrollment and biospecimen and data collection. Further, they need
optimal, complete follow-up of patients with cirrhosis to determine if the participants developed HCC. The BBDC
requires support programs and systems to track samples between enrollment sites to identify and select
samples for testing related to specific projects. All three PP studies also require rigorous advanced methods
for statistical analyses and information technology. All these needs will be addressed by the DAC.
The goal of the DAC is to provide critical expertise and support in data management, coordination, statistics
and information technology for all projects in the PP. The Specific Aims of DAC are to provide the PP projects
and BDCC with (1) Management and coordination, including implementing and maintaining a Manual of
Operation (MOO) of the multicity, multisite prospective cohort; (2) Programming and systems support to
maintain central databases for PP Projects, track samples, design programs to monitor study data, and develop
electronic dashboards to ensure regulatory compliance and timely progress of PP Projects and Cores; (3)
Statistical expertise for programming, ongoing quality assurance, study design guidance, and analysis and
interpretation of data; and (4) Informatics technology to harmonize data collection efforts among PP
investigators and collaborators and to develop apps for users that interface with simulation models.
DAC members have extensive experience and expertise in the design and statistical analyses of variety of
study as well as continuity of skills, protocols and personnel related to the THCCC cohort. DAC will ensure
the all Projects and Cores achieve the overarching goal of reducing HCC related mortality.

Grant Number: 5P01CA263025-04
NIH Institute/Center: NIH
Principal Investigator: Christopher Amos