ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Scientific guideline

The purpose of this document is to outline general principles for the planning and design of multiregional clinical trials with the aim of increasing their acceptability in global regulatory submissions. The document addresses some strategic programme issues as well as aspects specific to the planning and design of confirmatory MRCTs and should be used together with other ICH efficacy guidelines, including E2, E3, E4, E5, E6, E8, E9, E10 and E18.

Keywords: MRCT , multiregional, clinical trials, confirmatory trials, exploratory trials

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