Preventive and Early Treatment of Acute Lung Injury Clinical Trials Network- Pgh

描述（由申请人提供）：匹兹堡大学寻求加入PETAL网络，宾夕法尼亚州立大学好时医疗中心作为我们的卫星合作伙伴。我们的目标是作为临床中心全面参与PETAL网络，共同的使命是更好地理解、治疗和结局，为急性肺损伤（ALI）或急性呼吸窘迫综合征（ARDS）患者或有风险的患者提供治疗。我们已经组建了一个由高级思想领袖和才华横溢的研究人员组成的团队，他们在与ALI/ARDS相关的基础，转化，临床和结局研究方面具有专业知识。 我们详细介绍了我们的双重PI的资格，提出证据证明他们有能力作为网络领导者在定义工作，所需的运营解决方案，未来的机会以及创建材料以分享PETAL研究工作的科学成果。接下来，我们将介绍使我们的临床中心能够成功参与的功能，包括满足招募需求以及在关键和早期护理中心这样做。 我们的临床中心提出了两项PETAL评估和实施的干预性研究：雾化DNA酶作为ARDS预防策略的试验;以及协议神经肌肉阻滞作为ARDS早期治疗策略的试验。我们描述了每种干预措施的科学背景和关键特征，提出了我们的计划，包括临床结局评估和集中的生物标志物收集，并在适用的情况下考虑威胁和突发事件。 我们还描述了我们的研究和临床环境、IRB支持、程序，以确保适当的人类受试者保护，以适当的安全性获得和管理所有数据和生物标本，遵守所有培训和监管要求，并保持本地结构化监督，以确保网络内的最佳参与。

DESCRIPTION (provided by applicant): The University of Pittsburgh seeks to join the PETAL network, with Penn State University Hershey Medical Center as our satellite partner. Our goal is to participate fully in the PETAL network as a Clinical Center, with the shared mission of achieving better understanding, treatment, and outcomes for those with or at risk for acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). We have assembled a team of senior thought leaders and talented investigators with expertise in basic, translational, clinical and outcomes research relevant to ALI/ARDS. We detail the qualifications of our dual PIs, presenting evidence for their ability to work as a pat of the network leadership in defining work, operational solutions needed, future opportunities, and creation of material to share the scientific results for PETAL research efforts. We next note the features that allow our clinical center to successfully participate, including meeting enrollment needs and doing so in key and early care sites. Our clinical center proposes two interventional studies for PETAL evaluation and implementation: A trial of nebulized DNAase as an ARDS-prevention strategy; and trial of protocolized neuromuscular blockade as an ARDS early treatment strategy. We describe the scientific background, key features of each intervention, present our plans that include clinical outcome assessment and focused biomarker collection, and consider threats and contingencies where applicable. We also describe our research and clinical environments, IRB support, procedures to ensure appropriate human subjects protection, to obtain and manage all data and biospecimens with appropriate security, to comply with all training and regulatory requirements, and to maintain local structured oversight to ensure optimal participation within the network.