Core--Biostatistics

本申请中研究项目的最终目标是通过对疾病的遗传学，生物化学，免疫学和药理学以及这些生物学参数与临床结果之间的关联进行协调调查，提高我们对CLL的理解和治疗选择。重要的是这个项目的成功是与生物统计学的核心，谁将在临床和实验室研究项目的设计和分析提供援助的成员的合作，以及协助设计有前途的实验室，遗传和人口统计学研究结果的进一步探索在自然历史数据库通过这个程序项目组装。生物统计学核心的目的是提供以下服务，这些服务将被所有研究项目使用。1.为临床研究方案提供生物统计协作，包括临床研究的设计、实施、分析和报告的所有方面。2.为所有实验室研究提供生物统计协作，包括此类研究的设计、实施、分析和报告的所有方面，以及实验室结果与临床参数和结局的相关性。3.使用自然史数据库为探索性和确证性研究提供生物统计学方面的所有帮助。4.就数据库结构提供建议，并确保数据从数据库中轻松流出以供分析。5.协助监督中央和机构一级的数据管理，以维护和完善数据库。6.参与CRC的质量保证计划。7. 与联盟主任合作，制定有关数据共享和作者身份的指南和政策，并确保出版物中使用的数据的完整性。利用数据库中包含的实验室和临床信息以及组织库资源，参与拟议项目的内部科学审查。

The ultimate objective of the research projects in this application is to improve our understanding of, and our therapeutic options, in CLL through a coordinated investigation of the genetics, biochemistry, immunology and pharmacology of the disease and the associations between these biological parameters and clinical outcomes. Important to the success of this project is the collaboration with members of the Biostatistics Core, who will provide assistance in the design and analysis of the clinical and laboratory research projects, as well as assist in designing the further exploration of promising laboratory, genetic and demographic findings in the natural history database assembled through this Program Project. The purpose of the Biostatistics Core is to provide the following services that will be utilized by all the research projects. 1. To provide biostatistical collaboration for clinical research protocols, including all aspects of the design, conduct, analysis, and reporting of the clinical studies. 2. To provide biostatistical collaboration for all laboratory studies, including all aspects of the design, conduct, analysis, and reporting of such studies, as well as the correlation of laboratory results with clinical parameters and outcomes. 3. To provide all aspects of biostatistical assistance for exploratory and confirmatory studies using the natural history database. 4. To advice on database structure and assure easy flow of data out of the database for analysis. 5. To assist in the supervision of data management both at a central and a institutional level, in order to maintain and complete database. 6. To participate in the quality assurance programs of the CRC. 7. To work with the Consortium Director to develop guidelines and policies on data sharing and authorship, and assurance of the integrity of data used in publications. To participate in the internal scientific review of projects proposed suing the laboratory and clinical information contained in the database, as well as the tissue banking resources.