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

Current effective version

ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 5 - First version

Adopted Reference Number: EMA/CHMP/ICH/453276/2016 Legal effective date: 14/06/2018 Summary:

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.

Document history

ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 5 - First version

Adopted Reference Number: EMA/CHMP/ICH/453276/2016 Legal effective date: 14/06/2018 Summary:

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.

Overview of comments received by EMA on 'Draft ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 2b' - First version

Reference Number: EMA/605292/2017

Draft ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 2b - First version

Draft: consultation closed Consultation dates: 28/07/2016 to 28/01/2017 Reference Number: EMA/CHMP/ICH/453276/2016 Summary:

The purpose of this guideline 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 guideline 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.