Summary
Objectives:
Noninferiority trials have become commonplace in recent years. Like individual clinical
trials, meta-analyses can also investigate noninferiority. However, certain important
topics have to be considered.
Methods:
The proposed methods in this paper have their origin in the framework of noninferiority
trials and meta-analyses. This paper can therefore be seen as a combination of both
fields. Two issues are highlighted in the paper; difficulties in the choice of delta
for a noninferiority meta-analysis leading to different deltas and methods for meta-analyses with different analysis sets, based on the full-analysis
set with the intention-to-treat principle or the per-protocol population. Analytical
methods, sensitivity analyses, meta-regression, and a bivariate method are introduced.
The proposed graphical presentations support the analytical results.
Conclusion:
The confidence interval approach using meta-regression or bivariate methods is appropriate
using both analysis sets for meta-analyses investigating noninferiority.
Keywords
Meta-analysis - equivalence - choice of delta - population sets
