Sensitivity analysis in medical device clinical trials: Case Studies
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Ying Yang, FDA  *Yu Zhao, FDA 

Keywords: missing data, sensitivity analysis, medical device, clinical trial

One of the major challenges in analyzing and interpreting medical device clinical trials is how to deal with the inevitable missing data which may lead to biased inference of treatment effect. Many approaches have been proposed to adjust the analysis to take into account the missing data; however, different approaches, usually based on different assumptions, may lead to different conclusions. Therefore it is necessary to investigate the robustness of study results through a range of sensitivity analyses based on different assumptions. In this presentation, we will discuss several sensitivity analysis approaches used in medical device clinical trials and present corresponding case studies.