?CORE B The Biostatistics Core (Core B) will provide comprehensive, centralized biostatistical support for all four research projects. This support will integrate the biostatistical activities at the University of Texas MD Anderson Cancer Center (MDACC), Harvard University, and Children's National Health System (CNHS) at The George Washington University. These activities will include design of pre-clinical studies and clinical trials, data analysis, and data management. Dr. Peter Thall, PhD, who has collaborated with Drs. Shpall, Rezvani, Bollard, and Molldrem for many years on several different protocols and grants, will serve as Director of the Biostatistics Core. The Core personnel, Dr. Thall and Roland Bassett, MS, are highly experienced biostatisticians in the Department of Biostatistics of the MDACC. Dr. Thall, will coordinate the biostatistical support. Conduct of clinical trials will utilize the Biostatistics Department's Clinical Trial Conduct website.
The specific aims of Core B are to (1) coordinate and manage biostatistical activities and ensure that investigators have ready access to biostatistical consultation, including experimental design, statistical modeling, data analysis, scientific interpretation, and reporting, (2) provide statistical design, modeling, and data analysis for pre-clinical studies, (3) provide statistical design and infrastructure for conduct of clinical trials, including sequentially adaptive futility/safety monitoring and dose-finding, and (4) provide support for data management in collaboration with the Administrative Core. If needed, the Core will draw on other resources and personnel in the Biostatistics Department at MDACC.
-CORE B Implementation of established statistical methods for study design and data analysis, or development of novel methods as needed, are essential to ensure the scientific validity of the research projects.
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