最近の臨床試験における多重性の問題

—承認審査の事例検討—

抄録

Recently, complex testing strategies based on the closed testing principle have been used especially in global clinical trials to assess efficacy of an investigational drug. This may be due to multiple/co-primary endpoints, multiple doses and/or multiplicity consideration of key secondary endpoints. In this review, focusing on different situations in Japan for multiple/co-primary endpoints and multiplicity consideration of key secondary endpoints from Europe and America, I will outline multiplicity issues discussed in PMDA review examples.