Data Coordinating Center for Hemodialysis Pilot Studies Consortium

描述（由申请方提供）：血液透析初步研究联盟（HDPSC）将设计并开展新疗法的初步和可行性研究，以降低接受维持性血液透析治疗的患者的发病率和死亡率。这是来自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、电解质和高血压部门的申请，作为该联盟的数据协调中心（DCC）。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，为未来全规模随机对照试验的设计提供信息; 2)建立网络范围内的质量保证标准和实践，包括研究人员培训、现场监测和严格的数据监测和管理; 3）建立和应用标准化流程、程序和工具，以便联合体成员实施单独的试点和可行性研究方案; 4）为联合体活动提供全面的行政支持，包括指导委员会、数据和安全监测委员会以及联合体小组委员会的会议，并与核心实验室、阅读和成像中心建立分包合同; 5）促进FDA接受和/或确认HDPSC研究的拟议结局，并支持监管要求，包括在研究者IND下进行的研究的要求; 6）支持科学发现的编写，如摘要、演示文稿和出版物; 7）支持HDPSC辅助研究的开发，并实施由HDPSC指导委员会进行正式审查和批准的流程; 8）准备、记录并向NIDDK数据存储库传输联盟数据;以及9）与HDPSC参与临床中心和NIDDK合作，根据试点和可行性研究结果计划全面随机对照试验 该协会进行的研究。

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.