An overview of statistical planning to address subgroups in confirmatory clinical trials

摘要: The effects of treatments within demographic and clinical subgroups patients are major interest in most confirmatory trials. Potential factors for defining include gender, age, disease severity, geographic region. A statistical issue the interpretation treatment comparisons is whether role a subgroup inferential, supportive, or exploratory through respectively corresponding to primary, key secondary, hypothesis-generating assessment. This article discusses planning control type 1 error multiple that correspond scope prespecified inferential subgroups, it provides some suggestions addressing 2 can pertain supportive subgroups. Treatment without priori specification should always have very cautious accounts how random variation influence their pattern results, although sugge...