Statistics and Data Management Center-Comprehensive Sickle Cell Centers

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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.