Biostatistics Core

PROJECT SUMMARY/ABSTRACT – BIOSTATISTICS CORE
The role of the Biostatistics Core is to support the investigators of the Memorial Sloan Kettering Cancer Center
Pancreas SPORE in the computational and statistical aspects of their research efforts, including the design and
analysis of laboratory experiments, clinical trials, molecular profiling studies, and imaging studies. Prior to the
initiation of all studies, Core staff will consult with SPORE investigators to discuss the underlying scientific
premise and translational goals of the project, to help the investigators select the most efficient and robust
analytical methods, and to estimate sample sizes to ensure adequate power to address study objectives. In
laboratory experiments, Core members will assist in the formulation of the experimental design and in the
analysis and interpretation of the data at the conclusion of the study. For clinical studies, Core members will work
with SPORE investigators to outline the major scientific objectives; the population to be studied; primary,
secondary, and exploratory endpoints; experimental design; analysis plans; and a targeted sample size justified
in probabilistic terms. At the conclusion of the trial, data analyses will be performed to assess the outcomes of
the study. For molecular studies using human tissues, Core members will closely interface with the team
members performing bioinformatics analysis and will have primary responsibility for merging molecular and
clinical data, and for performing appropriate statistical and bioinformatics analyses. The members of the
Biostatistics Core will also work with SPORE investigators to format data for publication. For imaging studies,
Core members will assess the ability of different imaging modalities to localize pancreatic cancer. Imaging
studies and radiomics analysis will also be employed to identify potential biomarkers of response to treatment.
As the research studies proceed, Core staff will suggest modifications to the design and analysis plans as
appropriate. They will also assist investigators with the preparation of any necessary graphs and tables, the
interpretation of results, the preparation of presentations and manuscripts, and will consult on the design of
subsequent research. If current statistical methodology does not adequately address a research question,
alternative methodologies will be developed. The experienced and collaborative Biostatistics Core is well
configured to provide the SPORE with a high level of statistical leadership and support that will enhance the
efficiency, quality, and quantitative rigor of its science.

Grant Number: 5P50CA257881-04
NIH Institute/Center: NIH
Principal Investigator: MARINELA CAPANU