COPD Clinical Research Network - Data Coordinating Center

COPD 临床研究网络 - 数据协调中心

• 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
• 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

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（John Connett，PI）在公共卫生学院的生物统计学划分，与流行病学和肺医学的划分合作，建议建立和运营数据协调中心（DCC）的慢性阻塞性肺疾病临床研究网络。 该网络的目标是确定中度至重度COPD患者的死亡率，加剧和残疾的预防和治疗性干预措施。 网络进行的临床试验必须与治疗这种常见和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。 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个临床试验，同时进行2-3个协议。 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）制定和维护程序手册； 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，结果和不良事件； 8）对研究人员进行数据分析，并为手稿和科学演示做出贡献。 我们的小组在COPD和肺气肿的多中心临床试验方面具有16年的设计，进行和分析的经验，包括肺健康研究I，II，II，II，II，II，II，II，II，以及类维生素类药物治疗的肺气肿（FORTE）研究。 我们组建了一个由研究人员和专业员工组成的坚实而富有成效的团队，在生物统计学，临床试验，流行病学和肺医学方面具有相关专业知识，以及在数据管理，数据质量控制和统计分析方面的丰富经验。