Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods.

ABSTRACT:

Background/aims

Regulatory approval of a drug or device involves an assessment of not only the benefits but also the risks of adverse events associated with the therapeutic agent. Although randomized controlled trials (RCTs) are the gold standard for evaluating effectiveness, the number of treated patients in a single RCT may not be enough to detect a rare but serious side effect of the treatment. Meta-analysis plays an important role in the evaluation of the safety of medical products and has advantage over analyzing a single RCT when estimating the rate of adverse events.

Methods

In this article, we compare 15 widely used meta-analysis models under both Bayesian and frequentist frameworks when outcomes are extremely infrequent or rare. We present extensive simulation study

SUBMITTER: Hong H 

PROVIDER: S-EPMC8041270 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature