Data Coordinating Center for Hemodialysis Pilot Studies Consortium

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DESCRIPTION (provided by applicant): The Hemodialysis Pilot Studies Consortium (HDPSC) will design and conduct pilot and feasibility studies of novel therapies to reduce morbidity and mortality for patients treated with maintenance hemodialysis. This is an application from the Center for Clinical Epidemiology and Biostatistics and the Renal, Electrolyte and Hypertension Division at the University of Pennsylvania Perelman School of Medicine to serve as the Data Coordinating Center (DCC) for the consortium. The DCC will provide scientific expertise and operational support for pilot studies that will be conducted at the HDPSC Participating Clinical Centers. Specifically, the DCC will: 1) provide scientific leadership for the design, implementation, and analysis of targeted pilot and feasibility studies conducted by the HDPSC to inform the design of future full-scale randomized, controlled trials; 2) establish network-wide quality assurance standards and practices, including training of study personnel, site monitoring, and rigorous data monitoring and management; 3) establish and apply standardized processes, procedures, and tools for the implementation of individual pilot and feasibility study protocols by consortium members; 4) provide comprehensive administrative support for consortium activities including meetings of the Steering Committee, Data and Safety Monitoring Board, and consortium subcommittees, and establish subcontracts with core laboratories, reading, and imaging centers; 5) facilitate the acceptance and/or qualification by the FDA of outcomes proposed for HDPSC studies and support regulatory requirements including those for studies conducted under an investigator IND; 6) support the preparation of scientific findings as abstracts, presentations, and publications; 7) support development of HDPSC ancillary studies, and implement a process for formal review and approval by the HDPSC Steering Committee; 8) prepare, document, and transfer consortium data to the NIDDK Data Repository; and 9) partner with HDPSC Participating Clinical Centers and the NIDDK to plan full-scale randomized controlled trials informed by the findings of the pilot and feasibility studies conducted by this consortium.