CCC for NHLBI Prevention and Early Treatment of Acute Lung Injury PETAL Network

CCC 用于 NHLBI 预防和早期治疗急性肺损伤 PETAL Network

• 批准号: 8874281
• 负责人: DAVID Alan SCHOENFELD
• 金额: $ 909.56万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-17 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8874281
• 关键词: Acute; Acute Lung Injury; Admission activity; Adult Respiratory Distress Syndrome; Adverse event; Biological Markers; Caring; Cessation of life; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Network; Cluster randomized trial; Communication; Communities; Computer Assisted; Critical Care; Data; Data Quality; Data Reporting; Development; Early treatment; Ensure; Health; Infection; Institutional Review Boards; Leadership; Length of Stay; Life; Logistics; Lung; Manuscripts; Measures; Mechanical ventilation; Methods; Monitor; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Newsletter; Pathogenesis; Patients; Performance; Physicians; Prevention; Prevention trial; Process; Productivity; Protocol Compliance; Protocols documentation; Publishing; Quality Control; Randomized; Reporting; Research Infrastructure; Resources; Risk; Sampling; Site; System; Techniques; Trauma; United States; Writing; base; design; drug distribution; electronic data; experience; improved; injury prevention; innovation; meetings; mortality; novel; patient safety; prevent; programs; protocol development; response; symposium; targeted treatment; trial design; web site

DESCRIPTION (provided by applicant): This proposal is a response to the RFA-HL-14-015 for the coordinating center of the Clinical Trials Network for the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. We propose to provide leadership in the design, analysis and conduct of the studies of the PETAL Network and to provide the infrastructure and communications that will create a cohesive and productive group. Over the past 18 years we have served as the coordinating center of the Acute Respiratory Distress Syndrome (ARDS) Network under the leadership of an experienced clinical trials statistician and an acute care physician. We recently published our approach to the statistical and logistics issues of the ARDS Network. We propose to enhance those methods to improve performance of these activities for PETAL. Our proposal for the PETAL network focuses on the novel challenges of prevention trials. We suggest that the feasibility of a prevention trial depends on the choice of endpoint, in particular that studies using mortality as the primary endpoint would not be feasible with a conventional trial design and other clinical endpoints may be problematic. The optimal endpoint would be the occurrence of ARDS or a measure of the clinical consequences of ARDS. The proposal discusses the issues of cluster randomized trials and adaptive designs. We discuss the statistical and scientific issues in creating a biomarker resource for the PETAL Network. We also describe our proposals to increase productivity of the network by implementing an efficient IRB review process, plans for applying a computer-assisted technique to set network priorities, and plans for soliciting community involvement on an ongoing basis. We describe the methods we will use to provide the needed infrastructure (such as a remote data and trial management system) and the coordination of all network activities: data quality control, protocol compliance, protocol initiation, randomization, drug distribution, sample management, adverse event reporting, statistical reporting, data dissemination, communication, and logistics.

描述（由申请人提供）：该提案是针对预防和早期治疗急性肺损伤（Petal）网络的临床试验网络协调中心RFA-HL-14-015的回应。我们建议在花瓣网络研究的设计，分析和行为方面提供领导才能，并提供将创建一个凝聚力和富有成效群体的基础设施和通信。在过去的18年中，我们一直是经验丰富的临床试验统计学家和急性护理医生的领导下，在急性呼吸遇险综合症（ARDS）网络的协调中心。我们最近发表了有关ARDS网络统计和物流问题的方法。我们建议增强这些方法来提高这些活动的花瓣的性能。我们对花瓣网络的建议集中于预防试验的新挑战。我们建议，预防试验的可行性取决于终点的选择，特别是，使用死亡率作为主要终点的研究对于常规试验设计和其他临床终点可能是有问题的。最佳终点是ARDS的发生或ARDS临床后果的量度。该提案讨论了聚类随机试验和自适应设计的问题。我们讨论了为花瓣网络创建生物标志物资源的统计和科学问题。我们还描述了我们的建议，以实施有效的IRB审核流程，应用计算机辅助技术来设定网络优先级，以及持续征求社区参与的计划，以提高网络的生产率。我们描述了我们将使用的方法来提供所需的基础架构（例如远程数据和试验管理系统）以及所有网络活动的协调：数据质量控制，协议合规性，协议启动，随机化，药物分配，样本管理，不良事件报告，不良事件报告，统计报告，数据传播，通信和物流。