Biostatistics and Bioinformatics Core

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PROJECT SUMMARY/ABSTRACT The deployment of appropriate analytic techniques and careful data management are an essential component for all Roswell Park Ovarian Cancer SPORE projects. The Biostatistics and Bioinformatics Core (Core C) will ensure that essential biostatistics and bioinformatics supports and resources are readily available to all SPORE research projects. The goals of the Core are to improve the productivity of the Individual Research Project investigators, reduce the barriers for access to analytic expertise, maintain high standards for data collection and management, design and perform rigorous analytical strategies, and foster a collaborative and supportive research community. The Biostatistics and Bioinformatics Core will assist basic, translational and clinical researchers of the SPORE with proper formulation, refinement and execution of study objectives by applying the appropriate biostatistics and bioinformatics analyses, and providing the appropriate interpretation of their results, in terms of both strengths and limitations. We will ensure a priori that Developmental Research Program and Career Enhancement Program projects are feasible from a biostatistical and bioinformatics perspective. The Biostatistics and Bioinformatics Core will ensure that appropriate data are collected; the data are of the highest quality and meet regulatory standards for privacy; and the data are those required to answer a study question, necessary for administrative reporting, needed to establish protocol compliance, and/or will be included in a manuscript. We will prepare Data Safety Monitoring Board reports and post clinical trial results to clinicaltrials.gov in a timely and compliant manner and ensure compliance to NIH policy and assist with data sharing of SPORE data via the NCI Cancer Research Data Commons infrastructure and similar NIH-designated data repositories. The Biostatistics and Bioinformatics Core will develop and implement new and novel statistical and bioinformatics methodology and the related software as needed to address all study objectives. We will implement software solution and best practice to boost robust and reproducible research. Our proposed Biostatistics and Bioinformatics Core will capitalize on a number of existing, well-functioning, NCI-funded units housed within the Roswell Park Department of Biostatistics and Bioinformatics.