# Core E: Biostatistics & Informatics Core

> **NIH NIH U54** · ROSWELL PARK CANCER INSTITUTE CORP · 2020 · $460,398

## Abstract

The overarching goal of the Biostatistics and Informatics (BI) Core is to provide high quality and state-of-the-
art services in biostatistics and informatics to all research projects and data generating cores within the WNY
Center for Research on Flavored Tobacco Products (CRoFT). The BI core will provide cost-efficient and
centralized service for appropriate study design, data collection, secured data transfer, data quality control,
data harmonization, database management, biostatistical and bioinformatical data analysis, results
interpretation and reporting, as well as novel biostatistical and bioinformatical methods and tools development,
and training. The core lead Dr. Li and two core co-investigators Drs. McCall and Yan have extensive
experiences in biostatistics and bioinformatics, including study design, data collection, data quality control,
cross-sectional and longitudinal data analysis, DNA methylation and gene expression data analysis, novel
biostatistical and bioinformatical methods and tools development. The BI core will achieve the goal through the
following specific aims:
Aim 1: Study design support for ongoing and pilot projects. The BI core will provide support to rapid
response and career enhancement pilot projects within CRoFT to ensure appropriate research design methods
and adequate sample size resulted from power analysis. In addition, the BI core will advise investigators
conducting longitudinal studies on procedure for minimizing attrition and maximizing participation.
Aim 2: Data capture, quality assurance and harmonization. The BI core will set up a CRoFT database to
capture all data generated from projects and cores, conduct data quality control procedures to ensure the high
quality of the data, and conduct data harmonization through PhenX Toolkit to facilitate the data sharing across
all Tobacco Centers of Regulator Science (TCORS).
Aim 3: Statistical and bioinformatical data analysis, novel methods and tools development. The BI core
will standardize biostatistical and bioinformatical methods and tools for genomic data analysis, provide
epidemiological data analysis for identifying risks of emerging flavoring compounds associated with human
health, and develop cutting-edge novel biostatistical and bioinformatical methods and tools for integrated data
analysis across projects to categorize flavor risks.
Aim 4. Statistical and bioinformatical methods and tools training. The BI core will promote dissemination
of the novel biostatistical and bioinformatical methods and tools to all TCORS investigators through publicly
accessible seminars, symposia, and workshops.
The BI core will also partner with Administrative Core (AC) and Career Enhancement Core (CEC) and leverage
the resources within the University of Rochester Clinical and Translations Science Institute to provide robust
and centralized support to tobacco product regulator science.

## Key facts

- **NIH application ID:** 9999519
- **Project number:** 5U54CA228110-03
- **Recipient organization:** ROSWELL PARK CANCER INSTITUTE CORP
- **Principal Investigator:** Dongmei Li
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $460,398
- **Award type:** 5
- **Project period:** 2018-09-14 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9999519

## Citation

> US National Institutes of Health, RePORTER application 9999519, Core E: Biostatistics & Informatics Core (5U54CA228110-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9999519. Licensed CC0.

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