Biostatistics Core

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PROJECT SUMMARY During the last few decades, the development of novel and powerful statistical tools as well as increasing access to low-cost, high-speed computing have made significant impacts on cancer research. Consequently, an expanded and critical role has emerged for statisticians to collaborate in the investigative process, and more importantly, a higher and more rigorous standard has been established and accepted widely in the definition of scientific evidence. Notably, the rapid advances in genetics and genomics through large-scale molecularly targeted approaches to personalized medicine have presented new challenges in experimental design and data analysis. For example, next-generation sequencing and high-density genotyping generate complex high- dimensional datasets for hypothesis generation and inferential testing. Such rich datasets pose fundamental challenges in study design, data analysis, and results interpretation due to the large number of hypothesis tests, gene pathway effects, and complex gene-gene interactions. The Biostatistics Core will collaborate and consult with SPORE investigators on study design and data analysis of the proposed studies to ensure the translational research will satisfy high scientific standards for statistical rigor. The requested funding will provide biostatistical support to pre-clinical experiments in cell lines and animal models, biospecimen studies for correlative analysis, and clinical trials in Projects 1-3 as well as new studies in the Developmental Research Program (DRP) and Career Enhancement Program (CEP). In particular, the Biostatistics Core is a dedicated facility to provide ready and specialized access to a broad range of statistical expertise and data-related services. 1. Statistical expertise for the design, planning and conduct of animal experiments and human studies. Sample size considerations are critical in clinical trials as well as biospecimen studies using blood and tissue collected retrospectively and prospectively. Prospective study design includes interim monitoring plans and early stopping rules in early phase trials. 2. Statistical expertise for data analysis and interpretation of animal experiments and human studies. Data analysis plans for human subjects include the identification and validation of biomarkers in retrospective and prospective studies. 3. Database consultation on (a) forms design, including variable definitions and coding conventions (b) database specifications, including variable and output formats (c) quality control and audit processes. 4. Computing facilities and resources for statistical and database requirements, including data transfer, merging, sharing, and security. The SPORE projects may require transfer and merging of clinical, pathologic and molecular data from different databases and laboratories, while maintaining confidentiality of personal identifiers and protected health information.