# Biostatistics Core

> **NIH NIH P50** · DANA-FARBER CANCER INST · 2022 · $255,422

## Abstract

PROJECT SUMMARY
During the last few decades, the development of novel and powerful statistical tools as well as increasing access
to low-cost, high-speed computing have made significant impacts on cancer research. Consequently, an
expanded and critical role has emerged for statisticians to collaborate in the investigative process, and more
importantly, a higher and more rigorous standard has been established and accepted widely in the definition
of scientific evidence. Notably, the rapid advances in genetics and genomics through large-scale molecularly
targeted approaches to personalized medicine have presented new challenges in experimental design and data
analysis. For example, next-generation sequencing and high-density genotyping generate complex high-
dimensional datasets for hypothesis generation and inferential testing. Such rich datasets pose fundamental
challenges in study design, data analysis, and results interpretation due to the large number of hypothesis tests,
gene pathway effects, and complex gene-gene interactions.
The Biostatistics Core will collaborate and consult with SPORE investigators on study design and data analysis
of the proposed studies to ensure the translational research will satisfy high scientific standards for statistical
rigor. The requested funding will provide biostatistical support to pre-clinical experiments in cell lines and animal
models, biospecimen studies for correlative analysis, and clinical trials in Projects 1-3 as well as new studies in
the Developmental Research Program (DRP) and Career Enhancement Program (CEP). In particular,
the Biostatistics Core is a dedicated facility to provide ready and specialized access to a broad range of statistical
expertise and data-related services.
1. Statistical expertise for the design, planning and conduct of animal experiments and human studies. Sample
size considerations are critical in clinical trials as well as biospecimen studies using blood and tissue collected
retrospectively and prospectively. Prospective study design includes interim monitoring plans and early stopping
rules in early phase trials. 2. Statistical expertise for data analysis and interpretation of animal experiments and
human studies. Data analysis plans for human subjects include the identification and validation of biomarkers in
retrospective and prospective studies. 3. Database consultation on (a) forms design, including variable
definitions and coding conventions (b) database specifications, including variable and output formats (c) quality
control and audit processes. 4. Computing facilities and resources for statistical and database requirements,
including data transfer, merging, sharing, and security. The SPORE projects may require transfer and merging
of clinical, pathologic and molecular data from different databases and laboratories, while maintaining
confidentiality of personal identifiers and protected health information.

## Key facts

- **NIH application ID:** 10496037
- **Project number:** 1P50CA265826-01A1
- **Recipient organization:** DANA-FARBER CANCER INST
- **Principal Investigator:** David A Barbie
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $255,422
- **Award type:** 1
- **Project period:** 2022-08-01 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10496037

## Citation

> US National Institutes of Health, RePORTER application 10496037, Biostatistics Core (1P50CA265826-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10496037. Licensed CC0.

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