# Trial Design and Biostatistical Support Core

> **NIH NIH P01** · UNIVERSITY OF MINNESOTA · 2024 · $189,270

## Abstract

PROJECT SUMMARY/ABSTRACT
The Trial Design and Biostatistical Support Core provides a broad array of statistical services in support of
the three Projects and other three Cores. The Core will provide regular advice on experimental design, such
as selection of end points, sample size and power, and optimal use of animals. The Core is responsible for trial
design and all clinical data management as it relates to the proposed phase I and early phase II trials in
Projects 1 and 3. Prospective collection of clinical data is maintained in the Blood and Marrow Transplant and
Cell Therapies Program Database in a secure central location. The Core will perform expert statistical analyses
in a format consistent between Projects using techniques that are state of the art in practice. The Core will also
facilitate data sharing with the Program as well as the general scientific community.
The Core is staffed by experienced biostatisticians who have daily working relationships with the Project
investigators. The Core biostatisticians have been an integral part in the development of the Program and have
participated in this P01 for its entire history. The Core has access to all needed software. This dedicated Trial
Design and Biostatistics Core has easy access to Program investigators with each of the biostatisticians
specializing in the specific Project areas, gaining working knowledge in the field and helping provide the
tailored biostatistical support.

## Key facts

- **NIH application ID:** 10837858
- **Project number:** 5P01CA065493-27
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** CHAP T. LE
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $189,270
- **Award type:** 5
- **Project period:** 1997-09-15 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10837858

## Citation

> US National Institutes of Health, RePORTER application 10837858, Trial Design and Biostatistical Support Core (5P01CA065493-27). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10837858. Licensed CC0.

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