Data Coordinating Center for the HALT-Polycystic Kidney Disease Trials

HALT-多囊肾病试验数据协调中心

• 批准号: 8052848
• 负责人: Charity G Patterson (Moore)
• 金额: $ 114.61万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8052848
• 关键词: Adverse event; Advisory Committees; Advocate; Affect; Algorithms; American; Ancillary Study; Autosomal Dominant Polycystic Kidney; Award; Cessation of life; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Code; Combined Modality Therapy; Communication; Complex; Computer Retrieval of Information on Scientific Projects Database; Contractor; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Set; Databases; Deposition; Disease Progression; Doctor of Philosophy; End stage renal failure; Enrollment; Ensure; Epidemiologist; Generations; Genetic; Goals; Healthcare; Human Resources; Image; Kidney Diseases; Laboratories; Lead; Logistics; Magnetic Resonance Imaging; Monitor; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Online Systems; Outcome Study; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Polycystic Kidney Diseases; Process; Progress Reports; Quality Control; Randomized Clinical Trials; Recruitment Activity; Renin-Angiotensin-Aldosterone System; Reporting; Research; Research Design; Research Personnel; Role; Safety; Schedule; Services; Site; Specimen; Structure; System; Techniques; Testing; Time; TimeLine; Training; Universities; Work; biobank; blood pressure regulation; clinical research site; cohort; data management; data sharing; design; drug distribution; experience; genetic analysis; image processing; improved; member; repository; web site

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.

描述（由申请人提供）：匹兹堡大学医疗保健研究中心（CRHC）数据中心拟作为HALT-多囊肾病（PKD）试验的数据协调中心（DCC）协调数据收集和管理、研究监查、培训和质量控制以及跨研究中心共享研究服务。HALT-PKD试验包括在7个临床研究中心进行的2项随机临床试验，由一个中心成像机构（也在匹兹堡大学）、一个药物配送中心、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在9个小组委员会的帮助下管理，并由一个外部咨询委员会/数据安全和监测委员会监督。研究数据和生物标本保存在3个NIDDK存储库中。在研究A中，使用2x2析因设计评估研究药物对2个血压控制水平下结构进展的影响。研究B比较了ACE-I/AR B联合治疗与ACE-I单药治疗至基线估计GFR降低50%、ESRD或死亡的时间。CRHC数据中心目前负责协调CRISP II队列（Consortium of Radiologic Imaging Studies of PKD），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Web的数据管理系统，包括数据跟踪、输入、质量控制、安全监测和报告生成; 2）组织试验沟通，支持每个研究中心的招募和保留，并协调和监测数据、图像和生物标本的转移;以及3）计划和进行统计分析，以支持每项研究的目的。将CRISP II和HALT-PKD的DCC放在一起将提高数据管理、汇总和分析的效率，从而可能产生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中心试验中，以最大限度地减少HALT-PKD的停机时间。CRHC数据中心拥有博士级的统计学家，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。数据中心人员还带来了定制表格设计、按需研究进度报告和研究中心工作人员培训方面的专业知识。我们致力于及时完成我们的工作，并尊重临床PI和HALT团队的需求。