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PEATAL网络，宾夕法尼亚州立大学好时医学中心是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PEATAL网络，共同的使命是为有急性肺损伤(ALI)或急性呼吸窘迫综合征(ARDS)风险的患者实现更好的了解、治疗和结果。我们组建了一支由资深思想领袖和有才华的调查人员组成的团队，他们在与ALI/ARDS相关的基础、翻译、临床和结果研究方面具有专业知识。 我们详细介绍了我们的双重绩效指标的资格，展示了他们作为网络领导者的能力，在定义工作、所需的操作解决方案、未来机会和创建材料以共享花瓣研究工作的科学成果方面的能力。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，包括满足注册需求以及在关键和早期护理站点这样做。 我们的临床中心提出了两项干预研究来评估和实施Petal：作为ARDS预防策略的雾化DNA酶试验和作为ARDS早期治疗策略的原始化神经肌肉阻断试验。我们描述了每一次干预的科学背景、主要特征，提出了我们的计划，包括临床结果评估和重点生物标记物收集，并在适用的情况下考虑了威胁和意外情况。 我们还介绍了我们的研究和临床环境，IRB的支持，确保适当的人类受试者保护的程序，以适当的安全获取和管理所有数据和生物标本，遵守所有培训和监管要求，以及保持当地的结构化监督，以确保在网络中的最佳参与。

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.