This article considers a variety of issues associated with the role that clinical trials play in the evaluation of the benefits and risks (harms) of new therapies and with the communication of quantitatively assessed benefits and risks based upon the evidence derived from clinical trials. The article is organized into several sections that explore and discuss aspects of the challenging area of characterizing benefits and risks from clinical trials. We begin with a background on the interest in the topic, and then consider a theme that argues for the imbalance or asymmetry in the way benefits and risks in clinical trials are currently characterized, using examples from the medical literature to illustrate the points. We then comment on several topics, such as metrics for benefit:risk that are involved in other aspects of benefit:risk analysis, which relate to other articles in this issue. Finally, we make some concluding remarks on how to make progress in the future to improve benefit:risk analysis in clinical trials.
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