Prevention and Early Treatment of Acute Lung Injury Clinical Trials Network

描述(由申请人提供)：本提案的目的是支持NIH NHLBI急性肺损伤(PEAL)预防和早期治疗网络&GT的运行；该网络的目标是有效地测试预防和治疗早期急性肺损伤(ALI)和急性呼吸窘迫综合征(ARDS)的药物、设备和协议，从而改善患者的短期和长期结果。为了实现这一目标，调查人员将： 1.向指导委员会和小组委员会提供组织领导，以建立一个有序、合理的过程，以开发、选择和进行至少两项临床试验，并改进网络的结构和操作程序。 2.协作生成假设、开发方案、完善招募和数据收集技术和方法，以获取和分析临床数据和样本。这项工作将包括收集高质量的生物和遗传标本，使网络成员和网络以外的其他人能够研究急性肺损伤的基因组学、蛋白质组学和微生物组学。 3.在5.5年的时间里，至少招募220名具有性别和族裔代表性的受试者参加临床试验，以产生高质量的数据，以检验指导委员会提出的假设。 4.通过高知名度的科学出版物和演示文稿传播研究成果。

DESCRIPTION (provided by applicant): The objective of this proposal is to support the operation of the NIH NHLBI prevention and early treatment of acute lung injury (PETAL) Network> The Network's goal is to efficiently test drugs, devices, and protocols to prevent and treat early acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) thereby improving the short and long-term outcomes of patients. To achieve this goal the investigators will: 1. Provide organizational leadership to a Steering Committee and Subcommittees to establish an orderly, rational, process to develop, select, and conduct at least two clinical trials and to refine the Network's structure, and operating procedures. 2. Collaborate in the generation of hypotheses, development of protocols, and refinement of recruitment and data collection techniques and methods to acquire and analyze clinical data and samples. This effort will include collection of high quality biological and genetic specimens to allow Network members and others outside the network to study the genomics, proteomics and microbiome of acute lung injury. 3. Over 5.5 years recruit a minimum of 220, gender and ethnically representative subjects to clinical trials to generate quality data to test hypotheses posed by the Steering Committee. 4. Disseminate study results through high profile scientific publications and presentations.