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

描述（由申请人提供）：重症哮喘研究项目（SARP）的总体目标是通过在分子和细胞水平上纵向定义疾病，为儿童和成人重症哮喘及其亚表型的理解开发一种新的范式。宾夕法尼亚州立大学医学院公共卫生科学系提议作为SARP的临床协调中心（CCC）。CCC将为SARP提供生物统计领导和科学协调；设计和维护SARP运营管理系统；为SARP提供后勤及通讯支援；并为共享纵向协议分配资金。公共卫生科学系是唯一有资格作为SARP的临床协调中心，作为哮喘临床研究网络（ACRN）和儿童哮喘研究和教育（CARE）数据协调中心（分别于1993年和1999年成立）的所在地，以及自2009年以来的AsthmaNet DCC。该应用程序的PI和核心生物统计学家是David T. Mauger博士，他目前是CARE和哮喘网DCCs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知识库和监督委员会合作方面经验丰富的DPHS团队。该应用程序还包括一位非常强大的临床合作研究员，她在哮喘方面拥有丰富的研究经验，Joanna Floros博士。尽管在网络临床中心会有许多在该领域处于领先地位的临床研究员，但CCC人员与具有临床专业知识的当地联合研究员之间频繁、直接的互动极大地促进了CCC的活动。总之，宾夕法尼亚州立大学医学院公共卫生科学系通过其管理成功的数据协调中心的悠久历史，已经做好了成功实施和执行严重哮喘研究项目的准备。

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.