Core--Biostatistics

本计划申请中研究项目的最终目标是通过对慢性淋巴细胞白血病（CLL）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，以提高我们对慢性淋巴细胞白血病（CLL）的理解和治疗选择，包括从诊断到初始治疗干预的时间，对治疗的反应，进展时间和总生存期。 为了实现这一目标，实验室研究的结果将及时整合到临床研究中。 与生物统计学核心成员的合作对该项目的成功至关重要，他们将在临床和实验室研究项目的设计和分析中提供帮助，并协助设计进一步探索通过该计划项目组装的CLL数据库中的实验室相关发现。生物统计学核心（核心B）的目的是提供所有研究项目都将使用的以下服务。1. 为临床研究方案提供生物统计协作。这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。 这包括此类研究的设计、实施、分析和报告的所有方面，包括实验室结果与临床研究参数和结局的协调。3. 就数据库结构提供建议，确保数据的轻松流动以及数据库分析的进出。4. 协助监督中央设施和机构一级的数据管理，以维持准确和完整的计算机化数据库。5. 参与通过持续审计过程收集的数据的质量保证。6. 利用数据库中包含的实验室和临床信息以及组织库资源，参与对拟议项目的内部科学审查。

The ultimate objective of the research projects in this program application is to improve our understanding of, and our therapeutic options in, chronic lymphocytic leukemia (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, including time from diagnosis to initial therapeutic intervention, response to therapy, time to progression, and overall survival. To achieve this, results of laboratory studies will be integrated into the clinical studies in a timely fashion. Important to the success of this project 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 promoting laboratory correlative findings in the CLL database assembled through this program project. The purpose of the Biostatistics Core (Core B) is to provide the following services that will be utilized by all the research projects. 1. To provide biostatistical collaboration for clinical research protocols. This includes all aspects of the design, conduct, analysis, and reporting of the clinical studies. 2. To provide biostatistical collaboration for all laboratory studies. This includes all aspects of the design, conduct, analysis, and reporting of such studies, including the coordination of laboratory results with parameters and outcomes from the clinical studies. 3. To advise on the database structure, to assure easy flow of data and into and out of the database analysis. 4. To assist in the supervision of data management, both at the central facility and at the institutional level, to maintain an accurate and complete computerized database. 5. To participate in the quality assurance of the data collected through an ongoing audit process. 6. To participate in the internal scientific review of projects proposed using the laboratory and clinical information contained in the database, as well as the tissue banking resources.