This post was written by Paul Sheives.
In an effort to better streamline medical device clinical trials, FDA issued a guidance document that addresses the use of Bayesian methods in medical device clinical trials. FDA provides a general overview of Bayesian methods and discusses how they intersect with the design and analysis of medical device clinical trials. The advantages and challenges inherent when using Bayesian methods are discussed, and FDA offers some comparisons to more standard statistical methods. In particular, FDA notes that this methodology allows companies to combine data collected in previous studies with data collected in a current trial, and the combined data may provide sufficient justification for smaller or shorter clinical studies. The use of Bayesian methods in post-market studies is explored as well.