Assessment of Clinical Meaningfulness Based on Absolute and Relative Measures of Effect

• Activity Number: 646
• Type: Contributed
• Date/Time: Thursday, August 8, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Qi Jiang*+ and Steven Snapinn
• Companies: Amgen and Amgen
• Keywords: clinical meaningfulness ; time-to-event endpoint ; absolute ; relative ; competing risk

Abstract

When evaluating the clinical meaningfulness of a treatment effect based on a time-to-event endpoint, many researchers prefer absolute measures to a relative measure such as the hazard ratio. We have previously shown that two commonly used absolute measures, the risk difference and the difference in medians, directly contradict each other, and that the hazard ratio has more desirable properties than either absolute measure. However, our previous work was limited to situations where the endpoint is not affected by a competing risk. In this presentation, we will extend our previous work to consider the impact of a competing risk on the choice of a measure of effect to assess clinical meaningfulness.