The Biostatistics Core serves as a centralized resource to the investigators of the Antibody Targeted Radiation and Immunotherapy for the Treatment of Solid Tumors Program Project Grant (PPG), providing biostatistical expertise and clinical research management resources to all projects. The Biostatistics Core includes two Senior Biostatisticians (one is the Core Director), 1 Staff Biostatistician, a Quality Assurance Clinical Research Associate, and a Clinical Research Associate. The Biostatistics Core provides study design, sample size projections, safety monitoring, case form development, data collection, data quality assurance, statistical programming, summary and analysis of study results, and collaboration in writing abstracts and peer-review publications. Statistical analyses are performed using SAS, S-PLUS, R software packages, and specialty software. The Biostatistics Core ensures that the proposed research hypothesis will be measured, tested, and interpreted, independent of whether the data comes from basic science, translational or immunologic studies, imaging, or clinical trials. The Biostatistics Core will also continue to provide infrastructure for the management and integration of both existing and newly collected data through consistent and compatible data handling, which is particularly important given the large amount of data collected and processed as part of the Imaging Response Assessment Team (IRAT), the IRAT workstation that will employed for this PPG, and the important cross study analysis that will be conducted. The Core will continue to have an integral role in the scientific development, execution and analysis of all projects in the PPG, including clinical trials. Core investigators have extensive experience in quantitative methods for biomedical applications, including clinical, basic and translational science studies. The Core is committed to continue its leadership role in the scientific integrity of the PPG investigations, to participating in regular project and program meetings, and to providing rigorous and innovative input on all quantitative matters arising in the projects. Their contribution to each project promotes interdisciplinary interactions and innovative hypotheses for exploration. The Biostatistics Core has been involved in study design for each specific aims of the current proposal, and will continue to be a critical component to successful conduct of the PPG.
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