Clinical

该计划项目的生物统计核心由共济会癌症中心生物统计和信息学共享资源的成员组成。该核心的工作原则反映了皇家统计学会召集的研究与“人类第一研究”有关的统计和科学问题的工作组最近的一份报告中所述的原则(2007年3月)。他们的观点的例证是这样一句话：统计学家的意见涉及伦理、科学和公共卫生、报告标准、实用性和常识问题，而不仅仅是纯粹的方法论。此外，准备此应用程序的团队 还将支持对健全、安全和高效的数据系统以及适当的质量保证和质量控制程序的迫切需要。 为此，生物统计核心的主要目标是通过全面参与其活动来促进方案项目的科学和运作，就像它为准备这项申请所做的那样。这包括通过协商和协作在实验设计、质量控制、数据收集和管理以及统计数据分析方面提供协助和指导。 核心计划的具体目标如下： SA 1：协助进行实验设计并提供数据分析计划。 答复2：在必要和适当的时候开发新的生物统计方法 SA 3：为所有数据收集活动实施质量保证(QA)计划 SA 4：支持现有的数据库应用程序，并开发新的(必要时)数据库应用程序，用于数据收集和集成。

The Biostatistics Core for this program project is staffed with members of the Biostatistics and Informatics Shared Resource of the Masonic Cancer Center. The working principles of this Core reflect those delineated in a recent report from the working group convened by the Royal Statistical Society to study statistical and scientific issues related to 'First in man Studies' (March 2007). Their views are exemplified by the quote "Statistician's input concerns matters of ethics, science, and public health, reporting standards, practicality and common sense, not just the purely methodological." In addition, the team that prepared this application will also support the critical need for sound, secure and efficient data systems and appropriate quality assurance and quality control procedures. To that end, the primary objective of the Biostatistics Core is to contribute to the science and operation of the program project by participating fully in its activities as it has for the preparation of this application. This includes assistance and direction in experimental design, quality control, data collection and management, and statistical data analysis through consultation and collaboration. The Specific Aims of the Core are as follows: SA 1: Assist in experimental designs and provide data analysis plans. SA 2: Develop new biostatistical methods when necessary and appropriate SA 3: Implement Quality Assurance (QA) plans for all data collection activities SA 4: Support existing and develop new (when necessary) database applications for data collection and integration.