RL10 Statistical Analysis of Safety of Medical Devices
*Pablo Bonangelino, U.S. Food and Drug Administration 


What should the role of the statistician be in reviewing medical device safety. My understanding of the current role of the statistician is as follows: check claims of statistical significance; provide confidence intervals for select adverse events or categories of adverse events; explain the statistical meaning of no observed events for a specific adverse event or category. Are there currently other roles for the statistician? An additional question is whether safety concerns should influence the statistician's assessment of effectiveness. In other words, could considering safety reduce the "regulatory type I error" of the statistician, or should this be left to the clinicians. Finally, should we start thinking about a Guidance on the statistical assessment of safety?