Support for Multi-Region Trial Guidelines

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 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, Merck, and Pharmaceutical Research and Manufacturers of America.