Data Coordinating Center for the HALT-Polycystic Kidney Disease Trials

描述（由申请人提供）：匹兹堡大学卫生保健研究中心（CRHC）数据中心提议协调数据收集和管理，研究监测，培训和质量控制，以及跨站点共享研究服务，作为halt -多囊肾病（PKD）试验的数据协调中心（DCC）。HALT-PKD试验包括在7个临床地点进行的2项随机临床试验，这些临床地点由一个中央成像设施（也在匹兹堡大学）、一个药物配送中心、2个中央实验室和3个外部承包商提供支持。该联盟由指导委员会在9个小组委员会的帮助下管理，并由外部咨询委员会/数据安全和监测委员会监督。研究数据和生物标本存放在NIDDK的3个资料库中。在研究A中，使用2x2析因设计评估研究药物对2个水平血压控制的结构进展的影响。研究B比较了ACE-I/ARB联合治疗与ACE-I单药治疗的基线估计GFR、ESRD或死亡率降低50%。CRHC数据中心目前正在协调CRISP II队列（PKD放射成像研究联盟），我们将运用我们在PKD和数据管理和分析方面的专业知识：1)开发一个基于网络的数据管理系统，该系统包含数据跟踪、输入、质量控制、安全监测和报告生成；2)组织试验沟通，支持各站点的招募和保留，协调和监控数据、图像和生物标本的转移；3)计划并进行统计分析，以支持每项研究的目的。CRISP II和HALT-PKD的DCC共同定位将提高数据管理、汇集和分析的效率，从而可能导致新的假设和衍生研究设计。在CRISP II DCC无缝过渡到匹兹堡之后，我们迅速开发了一个基于web的数据管理和输入系统，并将应用我们之前的经验，将现有的DCC转移到正在进行的多站点试验中，以最大限度地减少hart - pkd的停机时间。CRHC数据中心拥有博士级别的统计人员，他们具备这项工作所需的专业知识，包括遗传学和相关数据的纵向分析。数据中心人员还提供定制表单设计、按需研究进度报告和现场员工培训方面的专业知识。我们致力于及时完成我们的工作，尊重临床pi和HALT团队的需求。

DESCRIPTION (provided by applicant): The Center for Research on Health Care (CRHC) Data Center at the University of Pittsburgh proposes to coordinate data collection and management, study monitoring, training and quality control, and shared research services across sites as the Data Coordinating Center (DCC) for the HALT-Polycystic Kidney Disease (PKD) Trials. The HALT-PKD trials comprise 2 randomized clinical trials conducted at 7 clinical sites supported by a central imaging facility (also at the University of Pittsburgh), a drug distribution center, 2 central laboratories, and 3 outside contractors. The Consortium is governed by a Steering Committee with help from 9 subcommittees and is overseen by an External Advisory Committee/Data Safety and Monitoring Board. Study data and bio-specimens are deposited in 3 NIDDK repositories. In Study A, the effect of study medication on structural progression at 2 levels of BP control is assessed using a 2x2 factorial design. Study B compares ACE-I/ARB combination therapy with ACE-I monotherapy on the time to a 50 percent reduction of baseline estimated GFR, ESRD or death. The CRHC Data Center currently coordinates the CRISP II cohort (Consortium of Radiologic Imaging Studies of PKD), and we will apply our expertise in PKD and data management and analysis to: 1) develop a Web-based data management system that incorporates data tracking, entry, quality control, safety monitoring, and report generation; 2) organize trial communications, support recruitment and retention at each site, and coordinate and monitor the transfer of data, images, and bio-specimens; and 3) plan and conduct statistical analyses to support the aims of each study. Co-locating the DCC for CRISP II and HALT-PKD will enhance the efficiency of data management, pooling, and analyses that could lead to new hypotheses and spin-off study designs. Following the seamless transition of the CRISP II DCC to Pittsburgh, we rapidly developed a Web-based data management and entry system and will apply our prior experience in moving an existing DCC for an ongoing multisite trial to minimize downtime for HALT-PKD. The CRHC Data Center has PhD-level statisticians with expertise needed for this effort, including genetics and longitudinal analyses of correlated data. Data Center personnel also bring expertise in customized form design, on-demand study progress reporting, and site staff training. We are dedicated to completing our work in a timely fashion and respecting the needs of clinical PIs and HALT team.