FDA publishes final ICH E17 Guidance on multi-regional trials

The U.S. Food and Drug Administration, FDA, published the final ICH E17 guideline on General Principles for Planning and Design of Multiregional Clinical Trials.

The draft ICH E17 document has been published for comment in 2016 and the final ICH E17 Guideline on Multi-Regional Clinical Trials reached Step 4 of the ICH Process in November 2017. It is now recommended for adoption to the regulatory bodies of ICH regions. This new ICH Guideline is proposed to provide guidance on general principles on planning/designing a Multi-Regional Clinical Trial (MRCT). It should be used together with other ICH guidelines, including E5 (Ethnic Factors), E6 (GCP), E8 (General Considerations), E9 (Statistical Principles), E10 (Choice of Control Groups), and E18 (Genomic Sampling).

The present guideline describes the principles for planning and design of MRCTs (= clinical trials conducted in more than one region under a single protocol) in order to increase the acceptability of MRCTs by multiple regulatory authorities.

Basic principles and key considerations for MRCTs are:

  • Participating regions should share a single primary analysis approach for hypothesis testing.
  • Common comparators should be used (comparators should in principle be the same in all participating regions). The selection of comparators should be discussed and agreed with the relevant regulatory authorities.
  • Selection of a primary endpoint which is considered clinically relevant in all regions (general principles for endpoint selection and definitions are provided in ICH E9).
  • Participating sites should be able to enroll a well-described, well-characterized population of eligible subjects (precisely defined inclusion and exclusion criteria that are acceptable and can be applied across all regions should be included in the protocol),
  • All sites participating in MRCTs should meet applicable quality and regulatory standards (compliance with GCP standards),
  • Monitoring plans should be pre-specified and implemented.
  • Timely and accurate flow of information should occur between the sponsor, the trial management team and participating sites.
  • It is recommended to have scientific consultation meetings, early in the planning stage, with the different regulatory authorities involved, and to obtain their agreement with the proposed overall development plan and the acceptability of MRCT data to support marketing authorization.

For more information please see the ICH´s Efficacy Guidelines page.

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