Biostatistics Core

生物统计学核心（核心B）将提供设计、实施和分析 临床试验、动物研究和相关研究项目。的目标 核心是在研究的所有阶段为六个项目提供生物统计支持。核心工作人员将 在研究开始前咨询研究者，以审查研究目的并协助选择 有效的设计和样本量，将提供足够的权力，以解决这些目标。为临床 研究，核心成员将与研究者一起进行方案审查，并协助方案制定， 样本量确定、中期分析计划以及随机化（如适用）。核心工作人员将 使用适当的统计数据为POI调查员进行统计分析和数据探索 方法;编写结果报告;协助编写介绍和编写 手稿的统计组成部分;并就后续研究的设计提供咨询。核心导演 在应用和方法学统计研究方面具有广泛的经验，这将允许最 拟采用的适当方法以及用于修改或开发新方法的方法， needed.

The Biostatistics Core (Core B) 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 phases of the research. Core staff will consult with investigators prior to the initiation of studies to review study objectives and assist in selecting efficient designs and sample sizes that will provide adequate power to address the 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 POI investigators using appropriate statistical methodologies; prepare reports of results; assist with the preparation of presentations and writing of statistical components of manuscripts; and consult on the design of subsequent research. The Core director has widespread experience in applied and methodologic statistical research, which will allow for the most appropriate methodologies to be utilized as well as for modification or development of new methods if needed.