Statistics and Data Management Center-CSCC Supplement

描述(由申请人提供)： 位于北卡罗来纳州教堂山的RHO联邦系统事业部(RhoFED)建议继续担任综合镰状细胞中心(CSCC)计划的统计和数据管理中心(SDMC)。SDMC将作为协调中心，支持协作临床研究、当地基础和临床研究，以及促进CSCC参与者和NHLBI项目办公室之间最佳沟通的活动。这些研究将集中在最有希望的镰状细胞疾病的治疗方式上。协调中心的主要目标是充当研究小组日常活动的中心通信点，在科学要素方面提供流行病学和统计合作，并提供工具和支持，以确保临床站点产生的数据具有最高质量。RhoFED认为以下四个目标对于满足该项目的业务和科学要求至关重要： A)为CSCC计划的通用临床方案提供数据管理、统计领导和临床操作管理支持；b)为CSCC计划内的所有研究项目提供统计支持；c)开发、实施和维护基于网络的信息技术，以促进CSCC计划内各机构之间的沟通，并为协作临床研究提供安全的数据输入和数据管理；d)维护、扩展和改进现有的CSCC计划公共患者数据库，特别强调纳入与镰状细胞疾病生活的社会和经济负担有关的数据以及与卫生服务利用、健康结果和生活质量相关的数据。

DESCRIPTION (provided by applicant): Rho Federal Systems Division, Inc. (RhoFED), located in Chapel Hill, North Carolina, proposes to continue to serve as the Statistics and Data Management Center (SDMC) for the Comprehensive Sickle Cell Centers (CSCC) program. The SDMC will act as a coordinating center in support of collaborative clinical studies, local basic and clinical research, and activities to promote optimal communication among CSCC participants and the NHLBI Project Office. These studies will focus on the most promising therapeutic modalities for sickle cell disease. The primary goals of the coordinating center are to act as central point of communication for the day-to-day activities of the study group, provide epidemiological and statistical collaboration in the scientific elements, and provide the tools and support to ensure that the data generated by the clinical sites are of highest quality. RhoFED considers the following four aims to be essential in meeting the operational and scientific requirements of the project: a) Provide data management, statistical leadership, and clinical operations management support for common clinical protocols for the CSCC program; b) provide statistical support for all research projects within the CSCC program; c) develop, implement, and maintain web-based information technology to facilitate communication across facilities within the CSCC program and secure data entry and data management for the collaborative clinical studies; d) maintain, expand, and improve the existing CSCC program common patient database with particular emphasis on incorporating data on the social and financial burden of living with sickle cell disease and data related to health services utilization, health outcomes, and quality of life.