COPD Clinical Research Network - Data Coordinating Cent*

COPD 临床研究网络 - 数据协调中心*

基本信息

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
项目类别：
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

项目摘要

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系（John Connett，PI），与流行病学和肺科医学部合作，提议建立和运营慢性阻塞性肺疾病临床数据协调中心 (DCC) 研究网．该网络的目标是确定预防和治疗干预措施降低中度至重度慢性阻塞性肺病患者的死亡率、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，并且必须对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，四到六个临床中心和 DCC 将启动并完成 4-5 个项目为期5年的临床试验，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并促进内部沟通； 2）提供研究设计的统计输入； 3）开发和维护手册程序； 4）建立分布式数据录入/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片中心建立分包合同； 7）生成随机化时间表和报告，以监控数据质量、招募进度、保留率、结果和不良事件； 8）为研究者进行数据分析并为手稿和科学贡献演示文稿。我们的团队为该项目带来了超过 16 年的设计、实施和分析经验 COPD 和肺气肿的多中心临床试验，包括肺部健康研究 I、II 和 III 以及类维生素A治疗肺气肿的可行性（FORTE）研究。我们已经组建了一支坚实而富有成效的团队由具有生物统计学、临床试验相关专业知识的研究人员和专业人员组成的团队流行病学、肺病学等，在数据管理、数据质量控制等方面拥有丰富的经验，和统计分析。