Abstract:
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In the safety and effectiveness evaluation of medical devices, randomized controlled trials (RCTs) provide the highest level of evidence. However, it is not always feasible to conduct an RCT due to practical or ethical reasons. As such, a single arm study in which comparison against a pre-specified performance goal is made plays a substantial role in pre-market device evaluation. While this type of study design has potential benefits, such as savings in cost or time, statistical challenges arise regarding the validity of study design and the interpretability of study results. In this presentation, we will discuss these challenges, focusing on issues with weighted performance goal.
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