ICH E17 Guideline access to new drugs worldwide by facilitating earlier approval across regions, thereby avoiding significant lag in the availability of new drugs in some regions. As shown in the illustrative examples in Figure 1, the timing of clinical drug development across different regions can be synchronised by the use of MRCTs, in comparison to local studies conducted independently in each region. Figure 1 also illustrates the use of MRCTs in the overall design of the drug development programme, not only in the con- firmatory stage, but also as an option in the exploratory stage, where it is feasible.
Early identification of relevant intrinsic and extrinsic factors could set a good foundation for planning confirmatory MRCTs. Figure 1. Illustrations of clinical drug development workflow across regions for drug submission and regulatory review in independent and global strategies *: Marketing Authorization Application/New Drug Application **: Could be parallel single region trials or MRCTs It may be plausible and efficient for an MRCT to be the single pivotal trial to support regulatory submission, and if this is the case, it should be designed to provide sufficient and robust evidence to support approval. 5