Issues and Challenges in Dichotomizing Continuous Variables in
Clinical Trials View Presentation View Presentation *Qi Jiang,
Amgen Inc.   Keywords: Dichotomizing, Clinical Trial,
Statistically Significant, Clinically Relevant, Responder
Analysis  One approach often proposed to ensure that a treatment
effect is both clinically meaningful and statistically
significant is known as a "responder" analysis. In this
approach, all subjects are classified as either responders or
non-responders based on the value of a continuous outcome
variable measured during the trial (or on a change from baseline
in that variable). While the responder analysis approach has
some appeal, it has disadvantages, such as the often arbitrary
nature of the definition of a response and a loss of statistical
power that can be considerable. In addition, the label
“responder” implies that individual changes in the response
variable are necessarily causal effects of the treatment. In
this presentation we will give an overview of responder anal