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Activity Number: 70
Type: Roundtables
Date/Time: Monday, August 4, 2008 : 7:00 AM to 8:15 AM
Sponsor: Section on Statistical Consulting
Abstract - #302273
Title: Statistical Consulting in the Medical Device Area: Using Secondary Data Sources for Development of Clinical Research Studies
Author(s): Madhu Mazumdar*+
Companies: Weill Cornell Medical College
Address: 411 E. 69th St, KB-323, New York City, NY, 10021,
Keywords: Medical Device ; Secondary Data Sources ; Total Joint Replacement ; Clinical Epidemiology ; Statistical Consulting ; Muscoskeletal disease
Abstract:

The identification and use of large data sources for medical device epidemiologic studies are important. This information helps improve knowledge for public health, regulatory decisions, and progress in clinical research. Limited information about both government and private data sources are available, but they are not sufficient for generating ideas for clinical research, especially for young investigators. A proactive role by the biostatistical consultant in gathering the type of research work already performed and dialogue about what more can be done could help start projects. These projects are typically of better quality as the statistician is involved from the beginning and can control the quality. A scenario in the context of joint replacement (knee, hip, and shoulder) will be discussed. Other examples are welcome.


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Revised September, 2008