JSM 2005 - Toronto

Abstract #303449

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 349
Type: Topic Contributed
Date/Time: Wednesday, August 10, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #303449
Title: Considerations in the Use of Composite versus Component Endpoints in Clinical Trials with Dropout
Author(s): Craig Mallinckrodt*+ and Christopher J. Kaiser
Companies: Eli Lilly and Company and Eli Lilly and Company
Address: Lilly Corporate Center, Indianapolis, IN, 46285, United States
Keywords: Global benefit ; composite endpoints
Abstract:

The risk-benefit evaluation of medicinal products traditionally has been based on combining individual outcomes (components) from clinical trials, often in an informal manner. More formal methods of determining a global risk-benefit measure are available. While these are intuitively appealing, any good assessment requires measures that reflect actual clinical practice outcomes and the relative "value" of these outcomes. This presentation will focus on two composite measures: Global Benefit Risk (GBR) mean change to last observation (LO). The GBR assessment combines efficacy and adverse events into a composite value, but determining the appropriate weightings for the components may be problematic. The LO analysis is numerically identical to last observation carried forward (LOCF) approaches, but is interpreted as a global (composite) measure of benefit-risk because the magnitude of observed improvement may be influenced by duration on therapy, which is in part a result of efficacy, safety, and tolerability. Whether the LO method appropriately measures and weights clinical practice risks and benefits is questionable.

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Revised March 2005