The Clinical Meaningfulness of a Treatment's Effect on Disease Progression

• Activity Number: 13
• Type: Topic Contributed
• Date/Time: Sunday, August 3, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Steven Snapinn*+
• Companies: Amgen
• Keywords: Overall Survival ; Hazard Ratio ; Difference in Medians

Abstract

In oncology clinical trials, the magnitude of a treatment's effect is often measured with respect to a time-to-event endpoint such as disease progression or overall survival using either a relative measure of effect, the hazard ratio, or an absolute measure of effect, the difference in medians between groups. In this presentation I will discuss the interpretation of these measurements with respect to clinical meaningfulness, focusing on two specific issues. First, assuming that the ultimate goal of treatment is to prolong survival, I will discuss the magnitude of treatment benefit on overall survival that can be expected from a specific magnitude of benefit on disease progression, and the factors that influence it. Second, I will contrast the hazard ratio and difference in medians as measures of treatment benefit, and argue that clinical meaningfulness should be assessed based on the relative measure of effect, the hazard ratio.