Multiplicity Considerations in Medical Device Clinical Studies
*Zengri Wang, Medtronic 

Keywords: Adaptive designs, Bayesian methods, hierarchical modeling, medical devices, multiplicity adjustment, subgroup analysis

Multiplicity needs to be clearly addressed for robust evidence in confirmatory medical device clinical trials. New issues emerge directly related to product approval and labeling when innovative trial designs and analyses are formulated to fit their capacity. In this presentation, review of current statistical practice on multiplicity adjustments in medical devices will be provided. New strategies to strengthen and optimize multiplicity, including Bayesian methods with informative priors, subgroup analyses and integrated safety/efficacy evaluations will be discussed. Practical examples will be used to illustrate how current methodology can be enhanced while retaining the high level of standards.