Abstract #302039

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JSM 2003 Abstract #302039
Activity Number: 437
Type: Topic Contributed
Date/Time: Thursday, August 7, 2003 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #302039
Title: Clinical Significance in Diagnostic Devices
Author(s): R. Lakshmi Vishnuvajjala*+
Companies: Food and Drug Administration
Address: 1350 Piccard Dr., MFZ-542, Rockville, MD, 20850,
Keywords: Diagnostic ; device ; clinical ; significance
Abstract:

When statistical significance is not achieved for the primary endpoint in a clinical trial, clinicians and statisticians usually agree on what the problem is. When a well-designed trial has clear and statistically significant results, it is often missed when clinical significance is questionable. This is particularly true in diagnostic devices for several reasons. For some in-vitro diagnostics, it is relatively inexpensive to overpower the studies. Some measures like area under the ROC curve are not as easily apparent, for example, as difference between two means. This is illustrated with examples from medical devices.

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