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)数据中心建议协调数据收集和管理、研究监测、培训和质量控制，并作为HALT-多囊肾病(PKD)试验的数据协调中心(DCC)跨地点共享研究服务。HALT-PKD试验包括在7个临床地点进行的2个随机临床试验，这些试验由一个中心成像设施(也在匹兹堡大学)、一个药物分销中心、2个中心实验室和3个外部承包商提供支持。该联盟由一个指导委员会管理，并由9个小组委员会协助，并由外部咨询委员会/数据安全和监测委员会进行监督。研究数据和生物标本保存在3个NIDDK知识库中。在研究A中，使用2x2析因设计评估研究药物在2个BP控制水平下对结构进展的影响。研究B比较了ACE-I/ARB联合疗法和ACE-I单一疗法在将基线估计的GFR、ESRD或死亡减少50%的时间上的差异。CRHC数据中心目前协调CRISP II队列(PKD放射成像研究联盟)，我们将应用我们在PKD以及数据管理和分析方面的专业知识来：1)开发一个基于Web的数据管理系统，其中包括数据跟踪、输入、质量控制、安全监测和报告生成；2)组织试验交流，支持每个地点的招募和保留，并协调和监测数据、图像和生物标本的传输；以及3)规划和进行统计分析，以支持每项研究的目标。将DCC用于CRISP II和HALT-PKD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，我们迅速开发了基于Web的数据管理和录入系统，并将应用我们先前在移动现有DCC进行多站点试验方面的经验，以最大限度地减少HALT-PKD的停机时间。CRHC数据中心有博士级别的统计学家，他们拥有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.