Data Coordinating Center for Hemodialysis Pilot Studies Consortium

描述（由申请人提供）：血液透析试点研究联盟（HDPSC）将设计和开展新疗法的试点和可行性研究，以降低维持性血液透析患者的发病率和死亡率。这是宾夕法尼亚大学佩雷尔曼医学院临床流行病学和生物统计学中心以及肾脏、电解质和高血压科作为该联盟数据协调中心（DCC）的申请。DCC将为将在HDPSC参与临床中心进行的试点研究提供科学专业知识和操作支持。具体而言，DCC将：1)为HDPSC进行的有针对性的试点和可行性研究的设计、实施和分析提供科学领导，为未来全面随机对照试验的设计提供信息；2)建立全网质量保证标准和实践，包括对研究人员的培训、现场监测和严格的数据监测和管理；3)建立和应用标准化的流程、程序和工具，以实施财团成员的个别试点和可行性研究协议；4)为联盟活动提供全面的行政支持，包括指导委员会会议、数据和安全监测委员会会议、联盟小组委员会会议，并与核心实验室、阅读中心和成像中心建立分包合同；5)促进FDA对HDPSC研究结果的接受和/或确认，并支持监管要求，包括在研究者IND下进行的研究；6)支持科学发现的摘要、报告和出版物的编写；7)支持HDPSC辅助研究的发展，并实施由HDPSC指导委员会正式审查和批准的程序；8)准备、记录和传输联盟数据到NIDDK数据存储库；9)与HDPSC参与临床中心和NIDDK合作，根据试点结果和可行性，计划全面的随机对照试验

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.