Coordinating Center for the Comparison of AMD Treatments Trials

AMD 治疗试验比较协调中心

• 批准号: 7171668
• 负责人: MAUREEN G MAGUIRE
• 金额: $ 389.9万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7171668
• 关键词: Medicare /Medicaid; blindness; clinical research; clinical trials; communication; data collection; data management; lead; macular degeneration; performance; reading

DESCRIPTION (provided by applicant): Age-related macular degeneration (AMD) is the leading cause of blindness in the United States and most western countries. The Comparison of AMD Treatment Trials (CATT) is a set of large-scale, randomized clinical trials designed to evaluate the relative efficacy and safety of alternative treatments for the neovascular form of the disease that accounts for approximately 90% of blindness due to AMD. The goal of the Coordinating Center is to contribute to the success of the CATT by providing study leadership, data management, data analysis, and communication, by facilitating the execution of the study protocol, and by coordinating the activities of the study group. The Coordinating Center provides expertise on design of multicenter clinical trials, implementation and maintenance of high quality data management systems, statistical analysis, and quality assurance in data management and clinical center performance. The specific aims of the Coordinating Center to fulfill this role are: Work with the other members of the study group to further refine the study design; Create and maintain the study database through design of data collection forms, data capture, data editing, and data management; Provide timely, regular reports concerning study progress and performance to the clinical sites, OCT Reading Center, Fundus Photograph Reading Center, Executive Committee and its subcommittees, and the Data and Safety Monitoring Committee; Design and implement a full program of quality assurance activities, in conjunction with the Executive Committee; Provide interim and final statistical analysis of the accumulated data on primary and secondary outcomes, as well as ancillary studies; Contribute to and distribute support materials for all CATT meetings; Maintain an up-to-date assessment of the status of treatments for AMD that are under development; Participate and lead in the preparation of scientific presentations and reports. Administer subcontracts with CATT clinical centers and work with the Center for Medicare and Medicaid Services to provide clinical centers with reimbursement for patient care; The CATT will identify the best treatments for "wet" age-related macular degeneration, the leading cause of blindness in Americans. The Coordinating Center works to make sure the clinical trials are successful.

描述（由申请人提供）：与年龄相关的黄斑变性（AMD）是美国和大多数西方国家失明的主要原因。 AMD治疗试验（CATT）的比较是一组大规模的随机临床试验，旨在评估该疾病的新生血管形式的替代治疗的相对疗效和安全性，该疾病的新生血管形式约占AMD引起的失明的90％。 协调中心的目的是通过促进研究协议的执行以及协调研究小组的活动，通过提供研究领导，数据管理，数据分析和沟通来为CATT的成功做出贡献。协调中心提供了有关多中心临床试验设计，高质量数据管理系统的实施和维护，统计分析以及数据管理和临床中心绩效质量保证的专业知识。 协调中心履行此角色的具体目的是：与研究小组的其他成员合作进一步完善研究设计；通过设计数据收集表，数据捕获，数据编辑和数据管理来创建和维护研究数据库； 及时提供有关研究进度和绩效的定期报告，向临床站点，OCT阅读中心，眼底照片阅读中心，执行委员会及其小组委员会以及数据与安全监测委员会；与执行委员会一起设计和实施完整的质量保证活动计划；提供有关主要和次要结果以及辅助研究的累积数据的临时和最终统计分析； 为所有CATT会议贡献并分发支持材料； 保持对正在开发的AMD治疗状况的最新评估；参与并领导科学演示和报告的准备。 使用CATT临床中心进行分包合同，并与Medicare和Medicaid服务中心合作，为临床中心提供以减少患者护理的费用； CATT将确定“湿”与年龄有关的黄斑变性的最佳治疗方法，这是美国人失明的主要原因。协调中心旨在确保临床试验成功。