“Points to Consider on Switching between Superiority and Non-inferiority”及び “Guideline on the Choice of the Non-inferiority Margin”の紹介

抄録

This paper introduces the contents of two documents from the European authority, “Points to Consider on Switching between Superiority and Non-inferiority” and “Guideline on the Choice of the Non-inferiority Margin”. Issues relevant to possible applications in Japanese clinical trials are also discussed.