ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process

The ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). This new ICH Guideline is proposed to provide guidance on general principles on planning/designing a Multi-Regional Clinical Trial (MRCT).

There are currently no ICH guidelines that deal with the planning and design of multi-regional clinical trials (MRCTs = clinical trials conducted in more than one region under a single protocol). The present guideline describes the principles for planning and design of MRCTs+ in order to increase the acceptability of MRCTs by multiple regulatory authorities. The guideline emphasizes that, at the moment, "it may be challenging both operationally and scientifically to conduct a drug development programme globally, in part due to distinct and sometimes conflicting requirements from regulatory authorities. At the same time, regulatory authorities face increasing challenges in evaluating data from MRCTs for drug approval. Data from MRCTs are often submitted to multiple regulatory authorities without a previous harmonised regulatory view on the study plan."

The present guideline "may facilitate a more efficient drug development and provide earlier access to medicines. In addition, MRCTs conducted according to the present guideline may enhance scientific knowledge about how treatment effects vary across populations and ethnicities under the umbrella of a single study protocol. This information is essential for simultaneous drug development to treat a broad patient  population."

Basic Requirements and Key Considerations for MRCTs are:

• Participating regions should share a unified trial hypothesis with common comparators (comparators should in principle be the same in all participating regions),
• A primary endpoint which is considered clinically meaningful in all regions (general principles for endpoint selection and definitions are provided in ICH E9),
• Participating sites should be able to enrol a well-described, well-characterised population of eligible subjects (clear and specific 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 ICH E6-GCP standards),
• Monitoring plans should be pre-specified and implemented,
• Timely and accurate flow of information should occur between the sponsor, 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.

Please see the Draft document  ICH E17 GENERAL PRINCIPLES FOR PLANNING AND DESIGN OF MULTI-REGIONAL CLINICAL TRIALS for more information.

The draft E17 Guideline is also available for download on the Efficacy Guidelines page on the ICH website. You are invited to provide comments on the draft E17 Guideline by e-mailing the ICH Secretariat. More details under the ICH Open Consultation page.