A new proposal for benefit-less-risk analysis in clinical trials.

In this paper, we propose a method to discount the observed benefit of a treatment by the observed risk in order to facilitate the benefit-less-risk comparison of treatments in a clinical trial. The discounting, applied to each individual in a trial, utilizes a method proposed by Chuang-Stein and co-authors to consolidate the safety data collected in the trial. The collating of the safety information allows one to estimate quantitatively the risk experienced by each individual, and therefore enables the construction of a risk-adjusted benefit measure for the same individual. We discuss the rationale for the adjusting method and examine its impact on the inference. When the discounting process reflects an individual's choice, the results should be interpreted at the individual level. An example is given to illustrate the approach.