The MRCT Center launched a new working group on June 18, 2015, as part of the MRCT Center’s partnership with Peking University.
The key objectives for the MRCT Working Group on Consistency and Region are:
- Develop methods for analyzing the consistency of regional sub-groups and the overall study data (trend analysis) for key safety and efficacy outcomes
- Review prior work already done to define region and agree upon a working definition for China
Fourteen individuals from academia and industry attended the initial meeting.
This work on multi-regional clinical trial issues of trend consistency, defining region and encouraging harmonization such that a single multi-regional clinical trial conducted would be acceptable for registration by all regulatory agencies is initially applicable to China. Furthermore, we see this as highly impactful work globally that will help China and other countries harmonize the “General principle on planning/designing Multi-Regional Clinical Trials” of the International Conference on Harmonization of Pharmaceuticals for Human Use (ICH E17).
If you are interested in joining this working group, please contact MRCT@BWH.HARVARD.EDU, with the subject line: Interest in joining Consistency and Region Working Group.