ICH E17 Guideline may enhance scientific knowledge about how treatment effects vary across regions and populations under the umbrella of a single study protocol, and how this variation may be explained by intrinsic and extrinsic factors. 1.3. Scope of the Guideline MRCT is defined in the present guideline as a clinical trial conducted in more than one region under a single protocol. In this context, a region may refer to a geographical re- gion, country or regulatory region (see Section 3. Glossary).
The primary focus of this guideline is on MRCTs designed to provide data that will be submitted to multiple regu- latory authorities for drug approval (including approval of additional indications, new formulations and new dosing regimens) and for studies conducted to satisfy post-market- ing requirements. Certain aspects of this guideline may also be relevant to studies con- ducted early in clinical development or in later phases. The present guideline mainly covers drugs including biological products, although some sections may not be applicable to all development programmes (e.g., pharmacokinetics (PK) not used for preventive vac- cine dose-finding). 1.4.
Basic Principles Basic principles for designing MRCTs are described below. Subsequent sections expand on these principles in more detail. 1. Strategic use of MRCTs in drug development programmes, properly designed and executed according to this guideline, can increase efficiency of drug development. MRCTs may enable simultaneous submission of marketing authorisation applica- tions and support regulatory decision-making in multiple regions, allowing earlier access to new drugs worldwide.
Although MRCTs may generally become the preferred option for investigating a new drug for which regulatory submission is planned in multiple regions, the potential for regional differences to impact the interpretability of study results should be carefully considered. 2. The intrinsic and extrinsic factors important to the drug development programme, should be identified early. The potential impact of these factors could be exam- ined in the exploratory phases before the design of confirmatory MRCTs. Infor- 2