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# Support for Multi-Region Trial Guidelines
- URL: https://www.fdaweb.com/support-for-multi-region-trial-guidelines/
- Published: 2016-12-08T12:00:00.000Z
- Updated: 2026-09-14T21:53:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137524

The Association of Clinical Research Organizations (ACRO) says it welcomes and supports creation of an International Conference on Harmonization guideline on multi-regional clinical trials (MRCTs). “ACRO’s view is that the draft guideline represents a very well-considered approach to the issues raised by MRCTs and is an excellent step forward in promoting their use,” the group’s comment [letter](https://www.regulations.gov/document?D=FDA-2016-D-2567-0005&ref=fdaweb.com) says. “ACRO especially welcomes the recognition that, when scientifically justified, flexibility can be built into a MRCT protocol in terms of regional differences in dosing regimen, active comparators and concomitant medication, endpoint-related subsections, sub-group analysis requirements, non-inferiority margins, regional sample size allocations in rare diseases, etc.” The letter includes specific comments on the text.

Responses with line-by-line specific comments were submitted by [Novo Nordisk](https://www.regulations.gov/document?D=FDA-2016-D-2567-0011&ref=fdaweb.com), [Merck](https://www.regulations.gov/document?D=FDA-2016-D-2567-0008&ref=fdaweb.com), and [Pharmaceutical Research and Manufacturers of America](https://www.regulations.gov/document?D=FDA-2016-D-2567-0009&ref=fdaweb.com).