# Core 2: Biostatistics/Clinical

> **NIH NIH P50** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $147,333

## Abstract

PROJECT SUMMARY/ ABSTRACT
The Biostatistical and Clinical Core will provide the expertise needed to support the laboratory and clinical
research of all four SPORE Projects and the Developmental Research and Career Enhancement projects. The
Biostatistical and Clinical Core provides critical support regarding experimental design, data capture and
management, data analysis, compliance, and reporting. Integration of the biostatistical and clinical research
teams represented in this Core ensures well-founded experimental designs at the planning phase, and their
ongoing interaction allows for any adjustments in the planned analyses and experiments to be optimized. A
single, shared Biostatistical and Clinical Core will improve performance of SPORE-driven projects and clinical
trials and will ensure that the work is performed in the most cost-effective and coordinated manner possible. In
addition, the leaders of this Core have considerable combined experience in dealing with the specific challenges
that arise in designing and conducting clinical studies for brain tumors. This includes knowledge regarding
molecular subtype analysis, neuroimaging endpoints, combination therapies, and toxicity assessments.
The Biostatistical Co-leader is Annette Molinaro, PhD, who will work with the individual leaders from all four
Projects to assess the statistical and database needs of each. She will provide advice on the design of
experimental and clinical studies, including the clinical trial in Aim 3 of Project 4; data analysis guidance (either
by performing the analyses within the core or advising qualified personnel within the projects), including the use
of appropriate statistical models and applications of statistical test; and, when appropriate, the development of
novel methods to help interpret results from experiments. Under Dr. Molinaro's supervision, the Core has
established and will expand and maintain the UCSF Brain Tumor Center Database, which will be the primary,
centralized repository for annotated data used by all SPORE investigators. This unique and customizable
resource will connect clinical information to imaging, tissue, and genomic parameters generated by the SPORE
projects.
The Clinical Co-leader, Susan Chang, MD, will interact with all Project leaders in the planning and conduct of
the clinical studies and assessment of results. This includes reviewing the prognostic value of the blood
immunomethylomics results from the population science studies in Project 1; assess the effect of novel metabolic
imaging studies planned in patients in Project 2 as they relate to important clinical endpoints; and to interpret the
results of Projects 3 and 4 to determine whether they can be used to reliably stratify patients by specific biological
pathways in future clinical trials. Most importantly, Dr. Chang will be instrumental in developing and conducting
a planned clinical trial based upon laboratory investigations in Project 4, projected for years 4 and 5 of t...

## Key facts

- **NIH application ID:** 9999428
- **Project number:** 5P50CA097257-18
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Susan M Chang
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $147,333
- **Award type:** 5
- **Project period:** 2002-09-20 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9999428

## Citation

> US National Institutes of Health, RePORTER application 9999428, Core 2: Biostatistics/Clinical (5P50CA097257-18). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9999428. Licensed CC0.

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