Clinical

该项目的生物统计学核心由共济会癌症中心的生物统计学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工作组最近的一份报告中所描述的原则，该报告旨在研究与“首次人类研究”（2007年3月）有关的统计和科学问题。他们的观点可以通过引用来说明：“Staecian的投入涉及道德，科学和公共卫生，报告标准，实用性和常识，而不仅仅是纯粹的方法论。“此外，准备这份申请的团队 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，生物统计学核心的主要目标是通过充分参与其活动，为该计划项目的科学和运作做出贡献，因为它已经准备了这一应用程序。这包括通过咨询和合作在实验设计、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。 核心的具体目标如下： SA 1：协助实验设计并提供数据分析计划. SA 2：在必要和适当时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，以进行数据收集和集成。

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.