Clinical Coordinating Center for the Severe Asthma Research Program (SARP)

描述(申请人提供)：重症哮喘研究计划(SARP)的总体目标是开发一种新的范式，通过在分子和细胞水平上纵向定义疾病，来理解儿童和成人的严重哮喘及其亚型。宾夕法尼亚州立医学院公共卫生科学系建议作为SARP的临床协调中心(CCC)。协调中心将为SARP提供生物统计领导和科学协调；设计和维护SARP业务管理系统；为SARP提供后勤和通信支持；并为共同的纵向议定书分配资金。公共卫生科学部是唯一有资格担任SARP临床协调中心的机构，自1993年和1999年成立以来，分别是哮喘临床研究网络(ACRN)和儿童哮喘研究和教育(CARE)数据协调中心的所在地，自2009年以来，是哮喘网络数据协调中心的所在地。该应用程序的PI和核心生物统计师是David T.Mauger博士，他目前是CARE和哮喘网疾病预防控制中心的PI。Mauger博士将领导一个在数据收集和管理、生物统计设计和分析、质量控制、网络基础设施开发和维护以及与国家信息库和监督委员会合作方面经验丰富的DPHS团队。这项申请还包括一位非常强大的临床合作研究员，具有广泛的哮喘研究经验，乔安娜·弗洛罗斯博士。尽管网络临床中心将有许多临床医生调查人员是该领域的领导者，但CCC人员与具有临床专业知识的当地合作调查人员之间的频繁、直接互动极大地促进了CCC的活动。总而言之，宾夕法尼亚州立大学医学院公共卫生科学系凭借其管理成功的数据协调中心的长期历史，已经做好了成功实施和执行严重哮喘研究计划的准备。

DESCRIPTION (provided by applicant): The overall goal of the Severe Asthma Research Program (SARP) is to develop a new paradigm for the understanding of severe asthma and its sub-phenotypes, in children and adults, by defining disease longitudinally at the molecular and cellular level. The Department of Public Health Sciences at the Penn State College of Medicine proposes to serve as the Clinical Coordinating Center (CCC) for SARP. The CCC will provide biostatistical leadership and scientific coordination for SARP; design and maintain the SARP operations management system; provide logistical and communications support for SARP; and distribute funds for a shared longitudinal protocol. The Department of Public Health Sciences is uniquely qualified to serve as the Clinical Coordinating Center for SARP, as the home of the Asthma Clinical Research Network (ACRN) and the Childhood Asthma Research and Education (CARE) Data Coordinating Centers since their inceptions in 1993 and 1999, respectively, and the AsthmaNet DCC since 2009. The PI and core biostatistician of this application is David T. Mauger, PhD, who is currently the PI of the CARE and Asthma Net DCCs. Dr. Mauger will head a DPHS team well-experienced in data collection and management, biostatistical design and analysis, quality control, network infrastructure development and maintenance, and working with national repositories and oversight committees. This application also includes a very strong clinical co-investigator with extensive research experience in asthma, Joanna Floros, PhD. Although there will be many clinician investigators at the network clinical centers who are leaders in the field, frequent, direct interaction between CCC personnel and local co-investigators with clinical expertise greatly facilitates the activities of the CCC. In summary, through its long history of managing successful data coordinating centers, Penn State College of Medicine's Department of Public Health Sciences is well poised to successfully implement and execute the Severe Asthma Research Program.