Core B: Biostatistics Core

University Of Texas Med Br Galveston, Galveston TX

Investigators

Linked publications, trials & patents

Abstract

Abstract The Biostatistics, Bioinformatics, and Clinical Trials Support (Biostats) Core will support all biostatistical and bioinformatics activities by providing centralized design consulting, coordination, data administration, and data analysis. This work is vital to ensure proper conduct of the study through efficient design and valid interpretations of clinical outcomes data. By acting as a centralized resource, the Core will also provide an opportunity to effectively explore synergies among the different project outcomes and improve understanding of the underlying biochemical systems. The personnel of the core will be able to provide a state-of-the-art understanding of design and analysis that thoroughly addresses any data needs of the project investigators. Additionally, the Core will provide database resource oversight for investigators to manage their data for analysis and quality control purposes. Core investigators will assure that all biostatistical activity is closely integrated with vital bioinformatics expertise, vital for ensuring proper access to every aspect of each investigator's data. All data brought to the Core will be coded and de-identified to ensure proper blinding and anonymity. Once the data within each project is properly analyzed to the satisfaction of the researchers, the PD, and the Biostatistics Core investigators, the non-coded treatment information will be provided by the Human Subject Core to allow the investigators to complete their associated manuscripts. Finally, the Biostatistics Core will provide as reports on safety and futility to the PD, PIs and Data Safety Monitoring Board as requested. Having this Core assist all projects with their data analysis and interpretation will also facilitate achieving the synergy envisioned when the P50 Burn Center was organized. By considering design issues across projects and incorporating measured predictors and endpoints into analytic modeling procedures, the Biostatistics Core will provide a platform upon which to more fully characterize the effects of Oxandralone with burn treatment outcomes.