Random-effects meta-analysis for systematic reviews of phase I clinical trials: Rare events and missing data.

ABSTRACT: Phase I trials aim to establish appropriate clinical and statistical parameters to guide future clinical trials. With individual trials typically underpowered, systematic reviews and meta-analysis are desired to assess the totality of evidence. A high percentage of zero or missing outcomes often complicate such efforts. We use a systematic review of pediatric phase I oncology trials as an example and illustrate the utility of advanced Bayesian analysis. Standard random-effects methods rely on the exchangeability of individual trial effects, typically assuming that a common normal distribution sufficiently describes random variation among the trial level effects. Summary statistics of individual trial data may become undefined with zero counts, and this assumption may not be readily examine

SUBMITTER: Kim MO 

PROVIDER: S-EPMC5149121 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature