Core C: Biostatistics and Bioinformatics

Vanderbilt University Medical Center, Nashville TN

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY/ABSTRACT: BBC The purpose of the Biostatistics and Bioinformatics Core (BBC) is to provide professional expertise in biostatistics and bioinformatics for all Vanderbilt-Ingram Cancer Center (VICC) SPORE in Gastrointestinal (GI) Cancer projects, investigators, and participants. BBC support is required for all VICC GI SPORE studies; core directors and core members are readily available to investigators and in routine contact with project and other core leaders via standing monthly meetings or ad hoc meetings or phone calls. One of the strengths of the VICC GI SPORE is involvement of biostatisticians and bioinformaticians from initial project stages to project completion. Core personnel function as collaborative members of research teams to ensure appropriate study design and methods of analysis to meet the endpoints of each project. In the study planning phase, core personnel work with GI SPORE investigators to define study objectives and endpoints, analyze pilot data, select an appropriate study design, devise blinding and randomization schemes, plan interim analyses, determine early stopping rules, compute adequate sample size with concern for clinical as well as statistical significance, estimate time required to meet recruitment goals for clinical studies, prespecify the data analysis plan including appropriate statistical and bioinformatic methods, and prepare statistical sections of protocols and grant applications. During study planning, also, core personnel work with investigators and the Tissue Pathology and Cellular Analysis Core (TPCAC) to develop a comprehensive understanding of data management needs for each VICC GI SPORE project. According to need, core personnel then may construct one or more data capture systems; integrate existing and/or newly developed systems; assist with refinement, expanded functionality, or standardization of existing systems; identify opportunities for and implement automation to minimize human time and error involved in data capture; and/or provide data quality control pipelines. As studies are conducted, core personnel work with investigators to monitor data collection for timely data accrual; run data quality pipelines to check and clean data; flag for review and work with investigators to address pervasive data quality concerns or other unanticipated problems that may arise during studies; execute interim analyses; monitor study safety; prepare, adapt, or develop methodology according to the predefined data analysis plan; and test the planned analysis pipeline against representative data types as study data accrue. After accrual of all study data, core personnel work with investigators to re-examine data, implement analysis pipelines according to the prespecified data analysis plan, generate statistical tables and figures, and write statistical and bioinformatic inputs and results for publication.