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（John Connett，PI）的生物统计学系， 与流行病学和肺医学的分歧合作，提议建立和 为慢性阻塞性肺疾病临床操作数据协调中心（DCC） 研究网络。网络的目标是确定预防性和治疗性干预措施 中度至重度COPD患者的死亡率，加剧和残疾。临床试验 网络进行的必须与临床实践有关，以治疗这一常见 严重的慢性病，​​必须为有关治疗替代方案的问题提供有效的答案。 如RFA HL-03-002中所述，四到六个临床中心，DCC将启动并完成4-5 在5年内进行临床试验，同时进行2-3个方案。作为网络的DCC， 我们将执行以下关键功能：1）建立网络的组织结构并促进 内部通信； 2）提供研究设计的统计输入； 3）制定和维护 程序； 4）建立分布式数据输入/数据管理系统； 5）火车和认证临床中心 人员; 6）根据需要与中央实验室和阅读中心创建分包合同； 7）生成 随机时间表和报告，以监视数据质量，招聘进度，保留率，结果以及 不利事件； 8）对研究人员进行数据分析，并为手稿和科学贡献 演讲。 我们的小组在设计，进行和分析的经验中为这个项目带来了这个项目 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 视网膜类似治疗的肺气肿（FORTE）研究的可行性。我们组装了一个坚实而富有成效的 研究人员和专业人员团队具有生物统计学，临床试验方面的专业知识， 流行病学和肺医学以及数据管理，数据质量控制方面的丰富经验， 和统计分析。