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This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 235
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2007 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #309710
Title: Primary Endpoint Sensitivity Analysis on Missing Data in Medical Device Trials
Author(s): Gina Garding*+ and Nathan Carter and Eric Bass and Paul Cernohous
Companies: Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation
Address: 4100 Hamline Avenue N., St. Paul, MN, 55112,
Keywords: Sensitivity Analysis ; Missing Data ; Data Imputation ; Medical Device Trials
Abstract:

It is becoming increasingly common that the FDA requests sensitivity analyses to assess the effect missing data could have on conclusions drawn from a medical device clinical trial. The assumption that the data is missing at random is sometimes questionable, requiring a sensitivity analysis. This analysis may be based on hypothetical situations, including "case" analyses (best, average and worst) or failure-threshold analysis. This presentation will compare the results of these analyses for binary endpoints.

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Revised September, 2007