ICH H ARMONISED G UIDELINE G ENERAL P RINCIPLES FOR P LANNING AND D ESIGN OF M ULTI -R EGIONAL C LINICAL T RIALS E17 ICH Consensus Guideline T ABLE OF C ONTENTS 1. INTRODUCTION ............................................................................................................ 1 1.1. Objectives of the Guideline ................................................................................................ 1 1.2. Background ........................................................................................................................ 1 1.3. Scope of the Guideline ....................................................................................................... 2 1.4.
Basic Principles .................................................................................................................. 2 2. GENERAL RECOMMENDATIONS IN THE PLANNING AND DESIGN OF MRCTS ........................................................................................................................................ 3 2.1 Strategy-related Issues ........................................................................................................ 3 2.1.1 The Value of MRCTs in Drug Development ............................................................ 3 2.1.2 Good Clinical Practice (GCP) Requirements and MRCTs .....................................
6 2.1.3 Scientific Consultation Meetings with Regulatory Authorities ............................... 6 2.2 Clinical Trial Design and Protocol-related Issues .............................................................. 7 2.2.1 Pre-consideration of Regional Variability and its Potential Impact on Efficacy and Safety ................................................................................................................................ 7 2.2.2 Subject Selection ..................................................................................................... 9 2.2.3 Selection of Doses for Use in Confirmatory MRCTs ............................................
10 2.2.4 Choice of Endpoints .............................................................................................. 11 2.2.5 Sample Size Planning ........................................................................................... 13 2.2.6 Collecting and Handling of Efficacy and Safety Information .............................. 18 2.2.7 Statistical Analysis Planning ................................................................................ 20 2.2.8 Selection of Comparators ..................................................................................... 23 2.2.9 Handling Concomitant Medications .....................................................................
25 3. GLOSSARY .................................................................................................................... 26 i