FDA Adopts ICH Addendum on Multiregional Clinical Trials

The US Food and Drug Administration on Wednesday adopted an addendum to the International Council for Harmonization's (ICH) guidance aimed at supporting drug sponsors in the collection of data from multiregional clinical trials (MRCTs). 

The guidelines in E17 General Principles for Planning and Design of Multi-Regional Clinical Trials detail seven “basic principles” to follow when designing MRCTs. 

Identified principles include “prespecified pooling of regions or subpopulations,” a “structured exploration to examine the consistency of treatment effects across regions and subpopulations,” and “efficient communication among sponsors and regulatory authorities." 

Another basic principle points to FDA's adopted version of ICH’s E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1), which was released in February, in the event of different regional practices such as to ensure the quality and interpretability of MRCT study results. 

It is important for MRCT data to be “accepted by regulatory authorities across regions and countries as the primary source of evidence to support marketing approval of drugs,” the 24-page ICH guidance states. 

The guidance also provides recommendations to address issues related to the planning and design of MRCTs, including those associated with choice of endpoints and comparators. 

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) became the first ICH member to adopt the guidance in June, the forum’s website shows.

FDA, Federal Register Notice