Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices.

Abstract

Integrating patient preferences into the design of randomized clinical trials (RCTs) may help accelerate innovation for alternative kidney replacement therapy by appropriately selecting a trial's significance level and sample size, and have a meaningful impact on people suffering from kidney failure. While a conventional one-sided significance level threshold of 2.5 % is often used to assess the safety of a proposed device, we show in this study that it is not necessarily consistent with the ris