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

描述（由申请方提供）：本提案是对急性肺损伤预防和早期治疗临床试验网络（PETAL）网络协调中心RFA-HL-14-015的回复。我们建议在PETAL网络研究的设计，分析和实施中发挥领导作用，并提供基础设施和通信，以创建一个有凝聚力和富有成效的团队。在过去的18年里，我们一直担任急性呼吸窘迫综合征（ARDS）网络的协调中心，由经验丰富的临床试验统计学家和急性护理医生领导。我们最近发表了我们对ARDS网络的统计和物流问题的方法。我们建议加强这些方法，以提高PETAL这些活动的性能。我们对PETAL网络的建议侧重于预防试验的新挑战。我们认为，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在传统的试验设计中是不可行的，其他临床终点可能存在问题。最佳终点是ARDS的发生或ARDS临床后果的测量。该提案讨论了群集随机试验和适应性设计的问题。我们讨论了为PETAL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，以提高生产力的网络，通过实施一个有效的IRB审查过程中，计划应用计算机辅助技术来设置网络的优先事项，并计划征求社区参与的持续基础上。我们描述了我们将用于提供所需基础设施（如远程数据和试验管理系统）和协调所有网络活动的方法：数据质量控制、方案依从性、方案启动、随机化、药物分发、样本管理、不良事件报告、统计报告、数据传播、通信和物流。

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.