COPD Clinical Research Network - Data Coordinating Center

COPD 临床研究网络 - 数据协调中心

基本信息

批准号：
7273693
负责人：
John E Connett
金额：
$ 291.79万
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/7273693
关键词：
Adverse event Area Behavioral Biological Markers Biometry Blood Certification Chronic Disease Chronic Obstructive Airway Disease Clinic Clinical Clinical Management Clinical Research Clinical Trials Collaborations Communication Communities Computer software Consent Data Data Analyses Data Coordinating Center Data Quality Development Disease Drug Labeling Eligibility Determination Emergency Situation End Point Ensure Epidemiology Facility Construction Funding Category Goals Health Heart Human Resources Institutes Investigation Label Laboratories Length Lung Manuals Manuscripts Mediation Medication Management Minnesota Monitor Morbidity - disease rate Operative Surgical Procedures Outcome Patients Pharmaceutical Preparations Pharmacologic Substance Placebos Preventive Procedures Process Protocols documentation Public Health Schools Publications Pulmonary Emphysema Pulmonology Quality Control Randomized 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 clinically relevant data management design disability distributed data experience follow-up mortality organizational structure protocol development quality assurance response

项目摘要

DESCRIPTION (provided by applicant): 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 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.

描述（由申请人提供）：明尼苏达大学公共卫生学院生物统计学系（John Connett，PI）与流行病学和肺医学系合作，提议建立和运营数据协调中心（ DCC）代表慢性阻塞性肺疾病临床研究网络。该网络的目标是确定预防和治疗干预措施，以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。该网络进行的临床试验必须与治疗这种常见且严重的慢性疾病的临床实践相关，并且必须为有关治疗替代方案的问题提供有效的答案。正如 RFA HL-03-002 中所述，四到六个临床中心和 DCC 将在 5 年内启动并完成 4-5 项临床试验，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）制定和维护程序手册； 4）建立分布式数据录入/数据管理系统； 5）对临床中心人员进行培训和认证； 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，以监测数据质量、招募进度、保留率、结果和不良事件； 8）为研究人员进行数据分析，并为手稿和科学演示做出贡献。我们的团队为该项目带来了超过 16 年的 COPD 和肺气肿多中心临床试验的设计、实施和分析经验，包括肺部健康研究 I、II 以及类视黄醇治疗肺气肿的可行性 (FORTE) 研究。我们组建了一支坚实而富有成效的研究人员和专业人员团队，他们拥有生物统计学、临床试验、流行病学和肺医学方面的相关专业知识，并在数据管理、数据质量控制和统计分析方面拥有丰富的经验。