Statistics and Data Management Center-Comprehensive Sickle Cell Centers

统计与数据管理中心-综合镰状细胞中心

• 批准号: 7629698
• 负责人: Karen Kesler
• 金额: $ 46.37万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-01 至 2012-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7629698
• 关键词: Achievement; Address; Adherence; Biological; Biological Markers; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Collection; Communication; Communities; DNA; Data; Data Analyses; Data Collection; Economics; Ensure; Funding; Genetic; Genomics; Genotype; Goals; Human Resources; Individual; Investigation; Leadership; Learning; Length; Manuals; Medical; Medical Research; Methods; Monitor; National Heart, Lung, and Blood Institute; Online Systems; Participant; Patient Outcomes Assessments; Patients; Phenotype; Positioning Attribute; Procedures; Process; Productivity; Program Development; Protocols documentation; Quality of life; Randomized; Reporting; Research; Research Design; Research Infrastructure; Resources; Review Committee; Role; Safety; Sampling; Scientific Advances and Accomplishments; Secure; Services; Sickle Cell; Sickle Cell Anemia; Statutes and Laws; Supervision; System; Techniques; Technology; Time; Training; Vision; Work; data management; design; disease registry; expectation; experience; health care service utilization; human subject protection; innovation; meetings; programs; quality assurance; repository; rho; social; statistics; web site

DESCRIPTION (provided by applicant): Rho Federal System Division, Inc. (RhoFED) proposes to continue to serve as the Statistics and Data Management Center (SDMC) for the Comprehensive Sickle Cell Centers (CSCC) Program. Our primary goals focus on increasing the productivity and efficiency of the CSCC Program, while maintaining high research standards and scientific integrity. During the 2008-2013 cycle, Rho will provide the full range of coordinating center services via the following specific aims: Management of effective communication, Provision of clinical research management, Expansion of the Collaborative Data Phenotype-Genotype Project (C-Data), and Provision of statistical leadership. A high priority will be given to early planning in conjunction with the NHLBI and the CSCC Steering Committee to streamline the protocol approval process, to eliminate avoidable delays in study start-up, and to move studies into the field as efficiently as possible. The scope of the NHLBI Comprehensive Sickle Cell Centers Public Information Website will be increased dramatically in order to disseminate relevant information to lay, research, and medical communities; and to include ready access to CSCC Center websites. Statistical leadership will go beyond provision of standard services to include introduction of innovative approaches to study design (e.g., adaptive designs), subject randomization, and analysis. The C-Data DMA and Biological Sample Repository will provide access to clinical and genetic data and to biologic samples for the scientific community at large, which will facilitate timely investigation of new hypotheses in sickle cell research. The successful partnership developed by Rho, the clinical centers, and the NHLBI during the past four years is evidenced by the significant achievements of the CSCC Program beyond those outlined in the previous RFA. Continued use of the current CSCC SDMC infrastructure and operational systems will provide a resource-efficient transition to the next funding cycle and facilitate program start up while allowing seamless completion of ongoing research efforts. Rho is uniquely positioned to fulfill the dual roles of research management and scientific guidance required to meet the goals of the original 1972 legislation creating the CSCC Program - development of new therapies and improvement in the quality of life of individuals with sickle cell disease.

描述（由申请人提供）： Rho联邦系统分部公司（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）。我们的主要目标是提高CSCC计划的生产力和效率，同时保持高研究标准和科学诚信。在2008-2013年周期内，Rho将通过以下具体目标提供全方位的协调中心服务：有效沟通管理，提供临床研究管理，扩展合作数据表型-基因型项目（C-Data），以及提供统计领导。将高度重视与NHLBI和CSCC指导委员会一起进行早期规划，以简化方案批准流程，消除研究启动过程中可避免的延迟，并尽可能有效地将研究转移到现场。NHLBI综合镰状细胞中心公共信息网站的范围将大幅扩大，以便向非专业人员、研究人员和医学界传播相关信息;并包括随时访问CSCC中心网站。统计领导将超越提供标准服务，包括引入创新方法进行研究设计（例如，适应性设计）、受试者随机化和分析。C-Data DMA和生物样本储存库将为广大科学界提供临床和遗传数据以及生物样本的访问，这将有助于及时调查镰状细胞研究中的新假设。Rho、临床中心和NHLBI在过去四年中建立的成功合作伙伴关系，证明了CSCC计划取得的重大成就超出了之前RFA中概述的成就。继续使用当前的CSCC SDMC基础设施和操作系统将为下一个资助周期提供资源有效的过渡，并促进项目启动，同时允许无缝完成正在进行的研究工作。Rho具有独特的定位，可以履行研究管理和科学指导的双重角色，以满足创建CSCC计划的1972年原始立法的目标-开发新疗法和改善镰状细胞病患者的生活质量。