# Sub-component for Institution # 16-01848 Biostatistics

> **NIH NIH P01** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2021 · $127,031

## Abstract

The primary goal of the Biostatistics Core (Core 2) will be to provide cost-effective, comprehensive and critical
support to the four projects and cores from this P01 application entitled “Maximizing Local Access to
Therapeutic Deliveries in Glioblastoma”. To do this Core 2 has assembled a team of experienced faculty and
staff statisticians and programmers. The Biostatistics Core will also act as a central resource throughout all
phases of the project. Members of Core 2 will assume (and has assumed) major responsibilities for
methodological, statistical, and computer-related issues, including study design for all projects; data collection,
data entry, and analyses; quality control; computer networking; database management; statistical methodology
development; and participation in manuscript preparation.
Core 2 has worked with each Project Leader to insure that each study design is adequate to address all major
hypotheses. This has involved refining study hypotheses, defining primary (and when necessary, secondary)
end points for each study; determining the sample sizes necessary to test each hypothesis with a specified
power and level of significance, and assessing the feasibility of each study relative to its hypothesis and the
projected available subject pool. Core 2 has taken care to design the statistical analysis plans for each project
to contain a combination of standard and advanced statistical methods as needed. This includes using
methods for longitudinal data that account for repeated measures as well as handling missing data if it were to
occur. In addition, Core 2 members will look for opportunities to develop new statistical methods for analyzing
imaging data and these approaches are described in the proposal.
To guarantee that successful implementation of these methods occurs, Core 2 members are committed to
taking an active part in the daily activities of each project. For each project one of Core 2 members will serve
as a co-investigator and participate in regular meetings among investigators for that project. This model of
collaboration among Core 2 members and scientific investigators has been implemented within the Cancer
Center at Wake Forest University for many years with great success. In conclusion, the Biostatistics Core is an
integral component of this P01. It connects the four projects together and supports all other Cores by providing
centralized analytic and data management support that will allow efficient dissemination of results to flow
among projects and cores, and into the scientific community.

## Key facts

- **NIH application ID:** 10220886
- **Project number:** 5P01CA207206-05
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Ralph B. DAgostino
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $127,031
- **Award type:** 5
- **Project period:** 2017-08-17 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10220886

## Citation

> US National Institutes of Health, RePORTER application 10220886, Sub-component for Institution # 16-01848 Biostatistics (5P01CA207206-05). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10220886. Licensed CC0.

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