The Dry Eye Evaluation And Management (DREAM) Study: Coordinating Center

干眼评估和管理 (DREAM) 研究：协调中心

• 批准号: 8415135
• 负责人: MAUREEN G MAGUIRE
• 金额: $ 200.03万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8415135
• 关键词: Address; Anti-Inflammatory Agents; Anti-inflammatory; Area; Artificial Tears; Asthenopia; Behavior; Biological Markers; Caring; Characteristics; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Design; Communication; Data; Data Analyses; Data Collection; Databases; Disease; Economic Burden; Effectiveness; Evaluation; Eye; Eye diseases; Fatty Acids; Fish Oils; Goals; Gray unit of radiation dose; HLA-DR Antigens; Health; Inflammatory; Knowledge; Laboratories; Lead; Leadership; Maintenance; Masks; Medical Care Costs; Monitor; Multicenter Studies; Omega-3 Fatty Acids; Pathogenesis; Patients; Performance; Physicians; Placebo Control; Population; Preparation; Prevalence; Protocols documentation; Provider; Quality of life; Randomized; Randomized Clinical Trials; Reporting; Research Design; Role; Safety; Signs and Symptoms; Supplementation; Symptoms; System; Testing; Time; Vision; Withdrawal; age related; chronic pain; clinical research site; cost; cytokine; data management; design; effective therapy; evidence base; eye dryness; improved; meetings; member; ocular surface; operation; primary outcome; productivity loss; programs; quality assurance; secondary outcome; success; treatment duration

DESCRIPTION (provided by applicant): The proposed Dry Eye Evaluation and Management (DREAM) study is a set of two multicenter randomized Clinical trials designed to evaluate effectiveness and safety of ? 3 fatty acid supplementation for treatment of patients with mild to moderate dry eye disease. Dry eye disease is a highly prevalent, age-related condition that in its mildest forms causes bothersome symptoms of ocular discomfort, fatigue, and visual disturbance, and in its severe forms causes chronic pain and fluctuating vision. The goal of the Coordinating Center (CC) is to contribute to the success of DREAM by providing study leadership, data management, data analysis, and communication, and by facilitating the execution of the study protocol. The CC provides expertise on design of multicenter studies and on implementation and maintenance of high quality data management systems, statistical analysis, and quality assurance programs. The specific aims of the Coordinating Center to fulfill this role are to: - Collaborate 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, the Central Laboratory for Fatty Acids and laboratories for HLA-DR and cytokine determination, the Executive Committee and its subcommittees, and the Data and Safety Monitoring Committee; - Design and implement a full program of quality assurance activities, with the Operations Committee; - Provide interim and final statistical analysis of the study data on primary and secondary outcomes; - Contribute to and prepare support materials for all DREAM meetings, including the Data and Safety Monitoring Committee, the Investigative Group, the Executive Committee, and the Operations Committee; - Participate and lead in the preparation of scientific presentations and reports; - Administer subcontracts with DREAM clinical centers.

描述（由申请人提供）：拟议的干眼评估和管理（DREAM）研究是一组两个多中心随机临床试验，旨在评估有效性和安全性？ 3补充脂肪酸，用于治疗轻度至中度干眼病患者。干眼症是一种非常普遍的与年龄相关的病，其最轻度的形式会引起眼部不适，疲劳和视觉障碍的令人讨厌的症状，其严重形式会导致慢性疼痛和视力波动。协调中心（CC）的目标是通过提供研究领导，数据管理，数据分析和沟通以及促进研究协议的执行来为梦的成功做出贡献。 CC提供了有关多中心研究设计以及高质量数据管理系统，统计分析和质量保证计划的专业知识。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，HLA-DR和细胞因子确定的脂肪酸和实验室中央实验室，执行委员会及其小组委员会以及数据和安全监测委员会； - 由运营委员会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的研究数据的临时和最终统计分析； - 为所有梦想会议的支持材料做出贡献，包括数据和安全监测委员会，调查小组，执行委员会和运营委员会； - 参与并领导科学演示和报告的准备； - 通过梦想的临床中心进行分包合同。