Why use Bayesian statistics for medical devices?
When good prior information on clinical use of a device exists, the Bayesian approach may enable FDA to reach the same decision on a device with a smaller-sized or shorter-duration pivotal trial. The Bayesian approach may also be useful in the absence of informative prior information. First, the approach can provide flexible methods for handling interim analyses and other modifications to trials in midcourse (e.g., changes to the sample size or changes in the randomization scheme). Second, the Bayesian approach can be useful in complex modeling situations where a frequentist analysis is difficult to implement or does not exist. Good prior information is often available for a medical device; for example, from earlier studies on previous generations of the device or from studies overseas. These studies can often be used as prior information because the mechanism of action of medical devices is typically physical, making the effects local and not systemic. Local effects are often predicta
