Biostatistics, Informatics, and Data Coordination

Duke University, Durham NC

Investigators

Linked publications & trials

Abstract

The overarching purpose of the Biostatistics, Informatics, and Data Coordination Core is to provide expert data analysis and data management to support all studies in the SPORE in Brain Cancer. Core B will ensure not only the timeliness and efficiency, but also the scientific integrity and quality, of the proposed SPORE studies by providing an infrastructure that offers, across studies: (1) expertise and technical support; (2) sophisticated but streamlined analytic, informatics, and data-related methods; (3) tools and procedures to help investigators exploit cutting-edge data and informatics capabilities while employing consistent, high-quality, research practices; and (4) a central access point that coordinates available resources such as institutional datasets. Staffed by biostatistics and informatics experts, database architects, computer scientists, and data managers, this Core builds upon and fortifies successful and longstanding collaborations with Brain SPORE and Duke Cancer Institute (DCI) investigators and our commitment to data standards and quality control. Core B leverages the Preston Robert Tisch Brain Tumor Center, DCI, and Duke University Health System shared resources, to provide SPORE investigators with centralized biostatistical expertise, state-of-the-art technology and database solutions, and access to an enduring coordinated data resource, tailored to meet the needs of brain cancer research. Specific aims addressed by this Core include: (1) To provide biostatistical leadership and expertise in the design, conduct, analysis, and reporting of Brain SPORE studies. Biostatistical collaboration will span all project stages: study design, sample size calculations, randomization, monitoring, analysis and interpretation, and manuscript preparation. (2) To be the SPORE data coordination center by providing services in data acquisition, transfer, integration, quality control, management and sharing for the SPORE in Brain Cancer Projects and Cores. In order to achieve this aim, Core B will ensure that there is a coordinated system for data collection, storage, and standardization; quality assurance and monitoring of data quality; access to tools and software; and promotion of data management best practices throughout the SPORE, including a system of common data management standardized operating procedures (SOPs) and agreed data governance, in order to ensure data integrity, provenance and security and reproducibility study findings. Finally, (3) To develop a longitudinal brain tumor outcomes database (?datamart?) that will serve as an enduring resource for brain cancer research at Duke. Leveraging institutional resources, this datamart will integrate information from Brain SPORE databases and institutional databases including clinical, health services and patient-reported outcomes to create a large clinical and research dataset for current and future analyses.