Biostatistics Core

生物统计学核心的目的是为科学项目和核心提供统计支持 在项目计划中。项目和核心的清单，以及对该核心的预计使用情况的估计 资源，见表1。 1.为临床研究项目提供生物统计合作。这包括设计的各个方面， 进行、分析和报告治疗干预的临床研究。生物统计支持也 扩展到管理未参与治疗方案的患者标本采集的方案。 2.为实验室研究提供生物统计合作。这包括所有方面， 分子、遗传、生化和免疫学研究的设计、实施、分析和报告 在患者或鼠样品上进行。 3.在规划和实施探索性分析时提供生物统计学援助， CRC数据库中的临床结果。 4.就数据库结构提供建议，以确保数据轻松流入和流出CRC数据库。 5.参与CRC数据库中收集数据的质量保证。 6.参与化学品审查委员会的内部科学审查机制，包括成为内部科学审查委员会的成员。 咨询委员会、临床咨询委员会和数据安全和监测委员会。 7.提供一个论坛，使在CLL工作的统计人员能够会面并分享对统计数据的见解。 对这种疾病的预后和预测分析的总结，并解决设计中出现的问题， CLL特异性I期和II期研究。

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.