COPD Clinical Research Network - Data Coordinating Cent*

COPD 临床研究网络 - 数据协调中心*

• 批准号: 7626197
• 负责人: John E Connett
• 金额: $ 340万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-15 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7626197
• 关键词: Adherence; Adverse event; Archives; Area; Authorship; Behavioral; Biological Markers; Biometry; Blood; Calendar; Certification; Chronic Disease; Chronic Obstructive Airway Disease; Clinic; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Communities; Computer software; Consent; Data; Data Analyses; Data Coordinating Center; Data Quality; Data Reporting; Development; Disease; Documentation; Drug Labeling; Eligibility Determination; Emergency Situation; End Point; Ensure; Epidemiology; Facility Construction Funding Category; Goals; Health; Heart; Human Resources; Institutes; Investigation; Label; Laboratories; Length; Logistics; Lung; Manuals; Manuscripts; Mediation; Medication Management; Minnesota; Monitor; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Paper; Participant; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Placebos; Preventive; Procedures; Process; Progress Reports; Protocols documentation; Public Health Schools; Publications; Pulmonary Emphysema; Pulmonology; Quality Control; Randomized; Rate; Reading; Reporting; Research; Research Design; Research Personnel; Respiratory physiology; Retinoids; Retrieval; Review Committee; Safety; Sample Size; Schedule; Screening procedure; Secure; Solid; Source; Specific qualifier value; Statistical Methods; System; Testing; Therapeutic Intervention; Training; Treatment Protocols; Universities; Visit; clinically relevant; data management; design; disability; distributed data; experience; follow-up; mortality; organizational structure; programs; protocol development; quality assurance; response; symposium

The Division of Biostatistics in the School of Public Health at the University of Minnesota (John Connett, PI), in collaboration with the Divisions of Epidemiology and Pulmonary Medicine, proposes to establish and operate the Data Coordinating Center (DCC) for the Chronic Obstructive Pulmonary Disease Clinical Research Network. The goals of the Network are to identify preventive and therapeutic interventions to reduce mortality, exacerbations, and disability in patients with moderate-to-severe COPD. Clinical trials undertaken by the Network must have relevance to clinical practice for the treatment of this common and serious chronic disease, and must provide efficient answers to questions regarding treatment alternatives. As described in RFA HL-03-002, four-to-six clinical centers and the DCC will launch and complete 4-5 clinical trials in a 5-year period, with 2-3 protocols in operation simultaneously. As the DCC for the Network, we will perform the following key functions: 1) establish the Network's organizational structure and facilitate internal communications; 2) provide statistical input on study design; 3) develop and maintain Manuals of Procedures; 4) establish a distributed data entry/data management system; 5) train and certify clinical center personnel; 6) create subcontracts with central laboratories and reading centers, as needed; 7) generate randomization schedules and reports to monitor data quality, recruitment progress, retention, outcomes, and adverse events; 8) carry out data analyses for the investigators and contribute to manuscripts and scientific presentations. Our group brings to this project over 16 years of experience in the design, conduct, and analysis of multicenter clinical trials of COPD and emphysema, including the Lung Health Studies I, II, and III and the Feasibility of Retinoid Therapy for Emphysema (FORTE) study. We have assembled a solid and productive team of investigators and professional staff with relevant expertise in biostatistics, clinical trials, epidemiology, and pulmonary medicine, and ample experience in data management, data quality control, and statistical analysis.

明尼苏达大学公共卫生学院生物统计学系（John Connett，PI）， 与流行病学和肺部医学部门合作，建议建立和 运营慢性阻塞性肺疾病临床数据协调中心（DCC） 中国互联网.该网络的目标是确定预防和治疗干预措施， 降低中重度COPD患者的死亡率、病情加重和残疾。临床试验 该网络所开展的工作必须与治疗这种常见疾病的临床实践相关， 严重的慢性疾病，必须提供有效的答案，有关治疗方案的问题。 如RFA HL-03 - 002所述，4 - 6家临床中心和DCC将启动并完成4 - 5个 临床试验在5年的时间内，同时运行2 - 3个方案。作为网络的DCC， 我们将履行以下主要职能：1）建立网络的组织结构， 内部沟通; 2）为研究设计提供统计输入; 3）开发和维护 程序; 4）建立分布式数据输入/数据管理系统; 5）培训和认证临床中心 人员; 6）根据需要与中心实验室和阅读中心签订分包合同; 7）生成 随机化时间表和报告，以监测数据质量、招募进度、保留、结局，以及 不良事件; 8）为研究者进行数据分析，并为手稿和科学贡献 介绍。 我们的团队为这个项目带来了超过16年的设计，执行和分析经验， COPD和肺气肿的多中心临床试验，包括肺健康研究I、II和III以及 维甲酸治疗肺气肿的可行性研究（FORTE）。我们已经组建了一个坚实而富有成效的 研究者团队和具有生物统计学，临床试验， 流行病学和肺部医学，以及在数据管理，数据质量控制， 和统计分析。