CORE--BIOSTATISTICS

生物统计核心负责提供协调、集中的数据管理支持，以及全面的生物统计咨询、数据分析和向与该应用有关的项目的所有方面进行报告。建议的项目包括两个多中心生物标志物调制临床试验(项目1和2)，以及一个相关的实验室项目(项目3)。临床研究的成功执行将需要参与者调查之间的密切协调，并与病理学核心。这将通过将临床数据管理活动集中在生物统计核心来促进。同样，中央数据管理将促进项目3的结果之间的联系，这些结果来自项目内部和病理学核心进行的分析。我们在这类数据管理方面有相当丰富的经验，预计在支持这些项目的需求方面不会有任何问题。所有项目的集中生物统计支助也将是这些项目的一项资产。它确保生物统计学家将完全熟悉项目的所有方面。除了有序和及时地监督和完成有计划的分析外，核心人员还可以帮助调查人员制定和测试这些密切相关的项目交叉受精可能产生的新假设。

The Biostatistics Core is responsible for providing coordinated, centralized data management support along with comprehensive biostatistical consultation, data analysis and reporting to all aspects of the projects related to this application. The proposed projects include two multi-center biomarker modulation clinical trials (Projects 1 and 2), and a related laboratory-based project (Project 3). Successful execution of the clinical studies will require close coordination among participant investigations, and with the Pathology Core. This will be facilitated by centralizing clinical data management activities in the Biostatistics Core. Similarly, central data management will facilitate linkage of results for Project 3 arising from within the project and from assays performed by the Pathology Core. We have considerable experience in data management of this type and anticipate no problems in supporting the needs of these projects. Centralized biostatistical support of all projects will also be an asset to the projects. It ensures that the biostatistician will be completely familiar with all aspects of the projects. In addition to overseeing and accomplishing planned analyses in an orderly and timely way, core personnel can help the investigators formulate and test new hypotheses that may arise by cross fertilization of these closely related projects.