For more than 60 years, this blank slate approach has been the Food and Drug Administration’s gold standard — and for good ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

The goal of this paper is to provide guidelines for appropriate questions that should be considered early in the design stage to facilitate the interactions between clinical and statistical teams and ...

Statistical fragility refers to the vulnerability of clinical trial results to minor changes in event outcomes. The fragility index quantifies this vulnerability by determining the minimum number of ...