? Biostatistics and Bioinformatics Core (Core 1) The Biostatistics and Bioinformatics Core will serve as an essential central resource to support the common quantitative needs of the three translational projects (Projects 1-3) as well as research developed within the Developmental Research (DRP) and Career Enhancement Programs (CEP). Building on decades of collaborative experience with Duke Brain SPORE investigators, the Core will use their expertise to help investigators frame study objectives and to ensure rigorous research design, conduct, analysis, and inference. The Core will provide biostatistical leadership and expertise in the study design, conduct, sample size calculations, randomization, monitoring, analysis, and reporting of clinical studies in brain cancer by collaborating at all project stages, from study design to interpretation and publication of results (Aim 1). In addition, Core 1 will contribute bioinformatics expertise to the conduct, analysis, and reporting of correlative studies associated with clinical trials (Aim 2). Expertise is provided for the analysis of data from polychromatic flow cytometry, intracellular staining, and TCR sequencing data. Finally, the Core will facilitate integration of clinical, laboratory, and correlative data generated by Projects and Cores, and to promote data integrity (Aim 3). In partnership with the Administrative Core, an exemplary research culture will be promoted where the best data management practices will be used throughout the SPORE in order to ensure data integrity, provenance and security, and reproducibility of study findings. Though oversight of quality control and quality assurance is provided by the Administrative Core, each individual Core has a role in maintaining data quality and providing an infrastructure within which reliable and valid data is gathered. This Core will provide infrastructure for the Clinical Trial Operations Core (Core 2) and the Biorepository, Pathology and Immune Monitoring Core (Core 3) to collect quality data, and will be responsible for the integration of data from various sources for statistical analyses. Taken together, the Biostatistics and Bioinformatics Core's contributions to investigating the safety, activity and mechanisms of novel immunotherapeutic approaches to the treatment of patients with glioma are critical to the achieving our shared goals of improving treatment of GBM.
? Biostatistics and Bioinformatics (Core 1) Malignant primary brain tumors are generally fatal, with devastating consequences for patients and their families. The Duke SPORE in Brain Cancer proposes a coordinated program of scientific discovery and translational research to enhance treatment of brain tumors and minimize their sequelae. This Biostatistics and Bioinformatics Core will provide biostatistical and bioinformatics expertise to support all studies in the SPORE in Brain Cancer, to ensure that reliable, reproducible results are generated that have maximal impact.
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