Are you using best practices to make safety and performance comparisons in your clinical study?

A client that produces a computerized surgical visualization system recently requested help with a clinical evaluation report in which comparisons needed to be made between their device’s safety & performance and the safety & performance of competitive devices represented in the published academic literature. Hensley Biostats performed meta-analyses and statistical tests to evaluate these outcomes, and also used best statistical practices and judgement to impute some unreported measures of dispersion that would otherwise have resulted in the exclusion of several published studies from the meta-analysis. This small project illustrates how even an apparently straightforward statistical objective like comparisons between groups can sometimes present issues requiring nuanced statistical decision-making informed by industry best practices.