FDA releases its final guidance document on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistics

February 2010

On February 5, FDA released its final guidance document on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistical methods.  Bayesian statistics is an approach for learning from evidence as it accumulates.

In clinical trials, traditional (frequentist) statistical methods may use information from previous studies only at the design stage. Then, at the data analysis stage, the information from these studies is considered as a complement to, but not part of, the formal analysis.  The Bayesian idea is to consider the prior information and the trial results as part of a continual data stream, in which inferences are being updated each time new data become available.