Research Center for Auditory and Vestibular Studies

描述（由申请人提供）：在过去的几年里，临床研究的数量和多样性在吴耳鼻喉科得到了巨大的发展。2002年是一个分水岭，中央聋人研究所增加了研究人员。由于临床研究部门和国家临床研究趋势的扩大，我们的研究人员在进行临床研究时遇到了一些障碍或障碍。这些障碍和障碍包括缺乏行政基础设施来协助研究者进行不同阶段的临床研究，不断增加的人体研究监管负担，有限的生物统计和方法支持，缺乏研究受试者招募基础设施，以及受试者招募的社区资源不发达。本补充申请旨在为圣路易斯华盛顿大学医学院耳鼻喉科已建立的NIDCD P30支持的听觉和前庭研究中心增加临床和转化研究核心。 本申请的具体目的是：1）通过聘请临床研究合规官和生物统计学家来扩大临床研究基础设施; 2）使用生物医学信息学技术：a）收集听力图、前庭报告和视听研究数据，并与全校范围的研究数据库合并，B）创建自愿研究参与者登记处，3）促进基础科学家和临床科学家之间的合作，以增加基础科学发现对人类应用的转化。WU临床和转化科学奖支持的生物医学信息学中心，研究设计和生物统计组，监管支持中心和社区参与核心的资源将用于协助临床和转化研究核心研究人员建立本申请中描述的研究基础设施。该申请还建议创建独特和新颖的翻译研究务虚会，研讨会系列，并通过部门资金支持试点合作研究的资金。该应用程序的最终影响将是改变临床研究和耳鼻喉科内的培训部门的行为，并与我们的基础科学同事合作，作为一个成功的转化研究计划的典范。 公共卫生相关性：该应用程序的最终影响是改变临床研究和临床研究培训在耳鼻喉科部门的行为，并与我们的基础科学同事合作，作为一个成功的转化研究计划的典范。 核心B 临床和转化研究核心 主任：约翰·列侬Piccirillo，医学博士

DESCRIPTION (provided by applicant): The volume and diversity of clinical research has grown enormously at WU Department of Otolaryngology over the past several years. The year 2002 was a watershed year with the addition of researchers from the Central Institute for the Deaf. As a result of the expansion of clinical research in the Department and national trends in clinical research, our investigators experience a number of blocks or barriers to the conduct of clinical research. Among these blocks and barriers are the lack of administrative infrastructure to assist investigators with the different phases of clinical research, growing human studies regulatory burden, limited biostatistical and methodological support, lack of research subject recruitment infrastructure, and underdevelopment of community resources for subject recruitment. This supplemental application is for the addition of a Clinical and Translational Research Core to the established NIDCD P30-supported Research Center for Auditory and Vestibular Studies in the Department of Otolaryngology at Washington University School of Medicine in St. Louis. The Specific Aims of this application are: 1) Expand the clinical research infrastructure through the hiring of a clinical research regulatory compliance officer and biostatistician; 2) Use biomedical informatics technology to: a) digitize audiograms, vestibular reports, and audiovisual research data and merge with campus-wide research databases , b) create a voluntary research participant registry, and c) utilize Web-based technologies to improve communication with the lay public and other researchers; 3) Promote collaboration between basic and clinical scientists to increase translation of basic science findings to human applications. The resources of the WU Clinical and Translational Science Award-supported Center for Biomedical Informatics, Research Design & Biostatistics Group, Regulatory Support Center, and Community Engagement cores will be used to assist the Clinical and Translational Research Core investigators build the research infrastructure described in this application. This application also proposes the creation of unique and novel translational research retreats, seminar series, and funding for pilot collaborative studies supported through Departmental funds. The ultimate impact of this application will be to transform the conduct of clinical research and training within the Department of Otolaryngology and, in collaboration with our basic science colleagues, to serve as a model for a successful translational research program. PUBLIC HEALTH RELEVANCE: The ultimate impact of this application is to transform the conduct of clinical research and clinical research training within the Department of Otolaryngology and, in collaboration with our basic science colleagues, to serve as a model for a successful translational research program. Core B Clinical and Translational Research Core Director: Jay F. Piccirillo, M.D.