有害事象の発現頻度の国際比較

抄録

In the condition of multiregional clinical trial, we considered the comparison with the frequency of adverse event between rigions. Several parameters, RRR (ratio of risk ratio), ORR (ratio of odds ratio) and PRRR (ratio of proportional reporting ratio), were defined to compare the frequency of adverse event. The influence of report bias was considered these parameters using modeled. report bias for drug adverse event between regions The RRR gave most robust estimator for several types report bias of adverse event between regions. The characteristics of RRR were examined by simulation using binomial random number on the several study conditions.