Q11
There seems to be an impression that the E5 bridging study would
always be conducted after data in the original region is complete. Is
this correct?
It may be desirable in certain situations to achieve the goal of
bridging by conducting a multi-regional trial under a common
protocol that includes sufficient numbers of patients from each of
multiple regions to reach a conclusion about the effect of the drug in
all regions. Please provide points to consider in designing, analyzing and evaluating such a multi-regional trial.
0 件のコメント:
コメントを投稿