Core-- Clinical Core

核心--临床核心

• 批准号: 7258888
• 负责人: Robert C Hyzy
• 金额: $ 83.49万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7258888
• 关键词: adult respiratory distress syndrome; biomedical facility; data management; human subject; information systems; informed consent; lung injury; medical outreach /case finding; patient safety /medical error; statistics /biometry

The mission of the Clinical Core is to provide the personnel, facilities, and organizational structure necessary to generate the clinical database and collect patient specimens for Projects 1,2,3,4, and 5. These resources will support individual protocols within the Core, facilitate interactions between investigators, and provide a cohesive framework for the formulation, execution, and data analysis of clinical research projects. The clinical protocol is designed to utilize the best strategies currently available for diagnostic assessment and management of acute lung injury (ALl) and acute respiratory distress syndrome (ARDS). Specific aims are: 1. To manage the clinical studies involving patients with ALI/ARDS including: a) Identify eligible patients, obtain informed consent, enroll and follow patients in a standardized protocol b) Collect clinical data to provide characterization of case mix, severity of illness, and risk stratification c) Prospectively classify patients into etiologic subgroups of ALI/ARDS d) Ensure patient safety through protocol compliance, study monitoring and reporting to the Institutional Review Board (IRB) and the Data Safety Monitoring Board (DSMB) 2. To procure cells and biological fluids for individual investigators: a) Perform bronchoaiveolar lavage (BAL) and blood collection in patients with ALI/ARDS, in ventilated patients without lung injury and in normal volunteers 3. To manage a clinical study utilizing GM-CSF in ARDS patients three days post meeting ALI/ARDS criteria: a) Identify eligible patients, obtain informed consent, enroll and follow patients b) Safely store, prepare and administer GM-CSF to patients randomized to receive study drug c) Ensure patient safety through protocol compliance, study monitoring and reporting to the institutional Review Board (IRB) and the Data Safety Monitoring Board (DSMB) 4. To provide data management services to individual investigators: a) Organize and manage the clinical database b) Advise on study design, sample size calculations and selection of appropriate outcome variables c) Allow etiologic subgroup specific interpretation of molecular biologic data d) Assist with statistical applications and data analysis.

临床研究中心的使命是为项目1、2、3、4和5提供必要的人员、设施和组织结构，以生成临床数据库和收集患者样本。这些资源将支持核心中心内的个别方案，促进研究人员之间的互动，并为临床研究项目的制定、执行和数据分析提供一个连贯的框架。临床方案旨在利用目前可用于诊断、评估和管理急性肺损伤(ALL)和急性呼吸窘迫综合征(ARDS)的最佳策略。具体目标是： 1.管理涉及ALI/ARDS患者的临床研究，包括： A)确定符合条件的患者，获得知情同意，按照标准化方案登记和跟踪患者 B)收集临床数据，以提供病例组合、病情严重程度和风险分层的特征 C)前瞻性地将患者归类为ALI/ARDS的病因亚组 D)通过遵守协议、研究监测并向机构审查委员会(IRB)和数据安全监测委员会(DSMB)报告，确保患者安全 2.为个别调查人员采购细胞和生物液体： A)对ALI/ARDS患者、无肺损伤的机械通气患者和正常志愿者进行支气管肺泡灌洗(BAL)和采血 3.对符合ALI/ARDS标准的ARDS患者在三天后使用GM-CSF进行临床研究： A)确定符合条件的患者，获得知情同意，登记和跟踪患者 B)安全地储存、制备和给随机接受研究药物的患者使用GM-CSF C)通过遵守协议、研究监测并向机构审查委员会(IRB)和数据安全监测委员会(DSMB)报告，确保患者安全 4.向个人调查人员提供数据管理服务： A)组织和管理临床数据库 B)就研究设计、样本量计算和选择适当的结果变量提供咨询 C)允许对分子生物学数据进行病因学亚组特定解释 D)协助统计应用和数据分析。