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: 7921093
• 负责人: James E. Bost
• 金额: $ 12.5万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-21 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7921093
• 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 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; improved; member; programs; 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，作为数据协调中心HALT-多囊肾病 (PKD) 试验中心 (DCC)。 HALT-PKD 试验包括 2 项随机临床试验，在 7 个临床中心进行，由中央成像设施（也在匹兹堡大学）、药物配送中心、2 个中心实验室和 3 个外部承包商支持。该联盟由指导委员会在 9 个小组委员会的帮助下进行管理，并由外部咨询委员会/数据安全和监测委员会监督。研究数据和生物样本存放在 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 个血压控制水平的结构进展的影响。研究B比较了ACE-I/ARB联合疗法与ACE-I单药疗法在基线估计GFR、ESRD或死亡减少50%的时间方面的情况。 CRHC 数据中心目前负责协调 CRISP II 队列（PKD 放射成像研究联盟），我们将运用我们在 PKD 以及数据管理和分析方面的专业知识来：1）开发基于 Web 的数据管理系统，其中包含数据跟踪、录入、质量控制、安全监控和报告生成； 2) 组织试验沟通，支持每个中心的招募和保留，并协调和监控数据、图像和生物样本的传输； 3) 计划并进行统计分析以支持每项研究的目标。 CRISP II 和 HALT-PKD 的 DCC 共置将提高数据管理、汇集和分析的效率，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，我们迅速开发了基于 Web 的数据管理和输入系统，并将应用我们之前将现有 DCC 迁移到正在进行的多站点试验的经验，以最大程度地减少 HALT-PKD 的停机时间。 CRHC 数据中心拥有博士级统计学家，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定制表格设计、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工作并尊重临床 PI 和 HALT 团队的需求。