# Core C: Biostatistics and Data Management

> **NIH NIH P01** · UNIVERSITY OF MINNESOTA · 2021 · $205,754

## Abstract

ABSTRACT 
 The Biostatistics and Data Management Core provides a broad array of statistical services in support of the 
four projects. The Core will provide advice on clinical trial design - such as selection of end points and 
possible stratification, consideration and calculation of sample size and statistical power. The Core is 
responsible for all aspects of data management in all four projects in this proposed Program Project (P01), 
“Consortium on Methods Evaluating Tobacco (COMET): Filter Ventilation and Product Standards”; we use 
secure databases with strong emphasis on data integrity and data quality. The Core will form plans and 
perform expert statistical analyses in a standardized format consistent between Projects using techniques that 
are state of the art. The Core will also facilitate data sharing between projects in the Center as well as the 
general scientific community. 
 The Core is staffed by a biostatistician serving as Protocol Manager (Data Manager) and four highly 
experienced biostatisticians who have daily working relationships with all principal investigators; two of the four 
biostatisticians are senior faculty (Associate Professors) of the Division of Biostatistics. The Core 
biostatisticians have been an integral part in the development of this application and have participated with this 
productive group of investigators the last 4-5 years of this current COMET grant. Additionally, the Core 
includes one biostatistician and one bioinformaticians at The Ohio State University who will focus on 
conducting studies involving complex multi-dimensional datasets. 
 The primary objective of the Biostatistics and Data Management Core is to contribute to the science and 
operation of the program project by participating fully in its activities. Core biostatisticians have broad long- 
standing expertise in clinical trial design, data collection, data storage, data retrieval, data analysis, and 
interpretation of results incorporating novel and complex statistical procedures as needed. By providing 
expertise research methodology and logistical support to data analytic activities with all three projects, this 
Core will help to enhance data interpretation and scientific productivity.

## Key facts

- **NIH application ID:** 10246925
- **Project number:** 5P01CA217806-05
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** Xianghua Luo
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $205,754
- **Award type:** 5
- **Project period:** 2017-09-20 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10246925

## Citation

> US National Institutes of Health, RePORTER application 10246925, Core C: Biostatistics and Data Management (5P01CA217806-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10246925. Licensed CC0.

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