This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 469
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #308269
Title: Benefit Risk Assessment Incorporating Time Component
Author(s): Paulette Ceesay*+ and Richard Entsuah
Companies: Merck & Co., Inc. and Merck & Co., Inc.
Address: 351 N. Sumneytown Pike, North Wales, PA, 19454,
Keywords: benefit risk ; ordinal data
Abstract:

It is imperative that both efficacy and safety are taken into consideration when evaluating the merit of drugs to ensure that patients are only exposed to drugs where the benefit outweighs the risk. Traditionally, efficacy and safety analysis evaluation of a new drug or dose is done separately. However, it may also be of interest to assess the comparative benefit risk. Current comparative risk assessment methods are unable to address some of the study designs and challenges that present themselves in clinical trials such as the incorporation of time. Using a generalized linear mixed model with random effects, methodology was constructed for evaluating the benefit risk profile of one drug versus another for ordinal longitudinal data. Some of the challenges and rewards of applying this strategy will be discussed. The approach was applied retrospectively to a Phase III clinical trial.


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