Biostatistics Core

生物统计核心的目的是为科学项目和核心提供统计支持 在计划项目中。项目和核心的清单，以及对这些核心的预计用途的估计 资源，见表1。 1.为临床研究项目提供生物统计协作。这包括设计的各个方面， 指导、分析和报告治疗干预的临床研究。生物统计学支持也 延伸到管理从没有参与治疗方案的患者身上收集样本的协议。 2.为实验室研究提供生物统计协作。这包括 分子、遗传、生化和免疫学研究的设计、实施、分析和报告 对病人或小鼠样本进行检测。 3.在规划和进行探索性分析方面提供生物统计援助，将实验室和 临床结果在CRC数据库中。 4.就数据库结构提出建议，以确保数据进出儿童权利委员会数据库的便利。 5.参与《儿童权利公约》数据库中收集的数据的质量保证。 6.参加儿童权利委员会的内部科学审查机制，包括内部科学审查机制的成员 咨询委员会、临床咨询委员会以及数据安全和监测委员会。 7.提供一个论坛，让从事CLL工作的统计学家能够会面并分享对统计的见解 本病的预后和预测分析的问题，并解决在设计中出现的问题 针对CLL的第一阶段和第二阶段研究。

The purpose of the Biostatistics Core is to provide statistical support for the scientific projects and the cores in the Program Project. A listing of the projects and cores, with an estimate of their projected use of this core resource, is provided in Table 1. 1. Provide biostatistical collaboration for clinical research projects. This includes all aspects of the design, conduct, analysis, and reporting of the clinical studies of therapeutic interventions. Biostatistical support also extends to the protocol governing specimen collection from patients not involved in therapeutic protocols. 2. Provide biostatistical collaboration for the laboratory research studies. This includes all aspects of the design, conduct, analysis, and reporting of the molecular, genetic, biochemical and immunological studies conducted on patient or murine samples. 3. Provide biostatistical assistance in the planning and conduct of exploratory analyses linking laboratory and clinical results in the CRC databases. 4. Advise on database structure, to assure the easy flow of data into and out of the CRC databases. 5. Participate in the quality assurance of the data collected in the CRC databases. 6. Participate in the internal scientific review mechanisms of the CRC, including membership on the Internal Advisory Board, the Clinical Advisory Committee, and the Data Safety and Monitoring Board. 7. Provide a forum in which statisticians working in CLL can meet and share insights into the statistical ssues of prognostic and predictive analyses in this disease, and address the issues which arise in designing CLL-specific phase I and phase II studies.