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# FDA Posts ICH Guide on Multi-regional Trials
- URL: https://www.fdaweb.com/fda-posts-ich-guide-on-multi-regional-trials/
- Published: 2016-09-08T12:00:00.000Z
- Updated: 2026-09-14T21:30:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136732

FDA has posted an International Conference (ICH) on Harmonization [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM519603.pdf?ref=fdaweb.com) on “General Principles for Planning and Design of Multi-Regional Clinical Trials” that describes how best to design drug trials so as to increase their data’s acceptability in multiple regulatory jurisdictions. The document addresses strategic program issues as well as those issues that are specific to the planning and design of confirmatory multi-regional clinical trials (MCRT). It should be used together with other ICH guidelines, including E2, E3, E4, E5, E6, E8, E9, E10 and E18.

“The underlying assumption of the conduct of MRCTs is that the treatment effect is clinically meaningful and relevant to all regions being studied,” the draft says. “ This assumption should be based on knowledge of the disease, the mechanism of action of the drug, on *a priori* knowledge about ethnic factors and their potential impact on drug response in each region, as well as any data available from early exploratory trials with the new drug. The study is intended to describe and evaluate this treatment effect, acknowledging that some sensitivity of the drug with respect to intrinsic and/or extrinsic factors may be expected in different regions and this should not preclude consideration of MRCTs.”

Planning for ethnic factors is also a major consideration when planning MRCTs, the guidance says. They should be identified during the planning stage, and information about them should also be collected and evaluated when conducting such trials. “Based on the understanding of accumulated knowledge about these intrinsic and extrinsic factors, MRCTs should be designed to provide information to support an evaluation of whether the overall treatment effect applies to subjects from participating regions,” it says. “For purposes of sample size planning and evaluation of consistency of treatment effects across geographic regions, some regions may be pooled at the design stage, if subjects in those regions are thought to be similar enough with respect to intrinsic and/or extrinsic factors relevant to the disease area and/or drug under study.”

In order to substantiate treatment effect consistencye, the guidance says consideration could also be given to pooling a subset of the subjects from a particular region with similarly defined subsets from other regions to form a pooled subpopulation whose members share one or more intrinsic or extrinsic factors important for the drug development program. “The latter approach may be particularly useful when regulators would like additional data to be available from a relevant subpopulation to allow generalizability to a specific population within their regulatory country or region,” it says.