The Biostatistics Core will provide biostatistical expertise in the design, conduct and analysis of the clinical trials, animal studies and related research projects generated under this proposal. The goals of the Core are to provide biostatistical support to the six projects at all stages of the research. Prior to the initiation of studies, Core staff will consult with investigators to review study objectives and assist in selecting efficient designs and sample sizes that will provide adequate power to address study objectives. For clinical studies, a Core member will conduct a protocol review with investigators and assist in protocol development, sample size determination, plans for interim analyses and if applicable, randomization. Core staff will perform statistical analyses and data exploration for P01 investigators using appropriate statistical methodologies; prepare reports of results; assist investigators with the preparation of presentations and writing of statistical components of manuscripts; and consult on the design of subsequent research. The biostatistical team also has widespread experience in applied and methodologic statistical research, which will allow for the most appropriate methodologies to be utilized as well as to modify or develop new methods if needed.
The Biostatistics Core is essential to the design, ongoing review and final analysis of preclinical experiments and clinical trials to translate biological questions into experimentally testable hypotheses yielding interpretable results and to insure that planned clinical trials are feasible, invoke appropriate design and stopping rules to insure safety and are appropriately analyzed and interpreted.
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