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. In October 2009, we were awarded a supplemental application 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. In the first seven months, we established the personnel infrastructure for the new Core by hiring two new staff members: a full-time Research Compliance Officer and a part-time Biostatistician. In addition, we have met with technical representatives of our Information Systems Pediatric Computing Facility to discuss several different projects to add in the conduct of clinical research, recruit subjects, and communicate the results of our research.
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-basecl 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 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, serve as a model for a successful translational research program.

National Institute of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Center Core Grants (P30)
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Special Emphasis Panel (ZDC1-SRB-Q (64))
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Washington University
Saint Louis
United States
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