Statistics and Data Management Center-Comprehensive Sickle Cell Centers

描述(由申请人提供)： RHO联邦系统分部(RhoFED)建议继续担任综合镰刀细胞中心(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，同时保持较高的研究标准和科学完整性。在2008-2013年期间，RHO将通过以下具体目标提供全方位的协调中心服务：管理有效的沟通、提供临床研究管理、扩展协作数据表型-基因项目(C-DATA)以及提供统计领导。将高度优先地与NHLBI和CSCC指导委员会一起进行早期规划，以简化议定书审批程序，消除研究启动过程中可避免的延误，并尽可能有效地将研究转移到该领域。NHLBI综合镰状细胞中心公共信息网站的范围将大幅扩大，以便向普通人、研究和医学界传播相关信息；并包括随时访问CSCC中心网站。统计领导力将超越提供标准服务的范围，包括采用创新方法进行研究设计(例如适应性设计)、对象随机化和分析。C-DATA DMA和生物样本库将为整个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。在过去的四年里，RHO、临床中心和NHLBI建立了成功的合作伙伴关系，CSCC计划取得了超出前一届RFA概述的显著成就。继续使用当前的CSCC SDMC基础设施和运营系统将提供到下一个资金周期的资源高效过渡，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处于独特的地位，能够履行研究管理和科学指导的双重角色，以满足1972年创建CSCC计划的原始立法的目标-开发新疗法和改善镰状细胞疾病患者的生活质量。

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.