COPD Clinical Research Network - Data Coordinating Cent*

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)与流行病学和肺部医学系合作，建议建立和运营慢性阻塞性肺疾病临床研究网络的数据协调中心(DCC)。该网络的目标是确定预防和治疗干预措施，以减少中重度COPD患者的死亡率、病情恶化和残疾。该网络进行的临床试验必须与治疗这一常见和严重慢性病的临床实践相关，并必须有效地回答有关替代治疗的问题。 如RFA HL-03-002中所述，4至6个临床中心和DCC将在5年内启动并完成4至5项临床试验，同时运行2至3项方案。作为该网络的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交流；2)就研究设计提供统计信息；3)制定和维护程序手册；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，并为手稿和科学报告做出贡献。 我们团队为该项目带来了超过16年的设计、实施和分析COPD和肺气肿多中心临床试验的经验，包括肺健康研究I、II和维甲酸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调查团队和专业人员团队，他们拥有生物统计学、临床试验、流行病学和肺部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。

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.