Multi-regional Clinical Trials (MRCTs) are an effective way to make cutting edge therapies available globally while still addressing the needs of diverse populations, however keeping up with regulations, such as ICH guideline (E17), can be challenging.
This Webinar discusses ICH guideline E17 that is extremely important to statisticians working on clinical trials spanning multiple regions. It shares a summary of the discussions that took place at the ICH meeting in Japan in November 2016, prepared by event attendees, to begin revising the guideline.
Download the DIA Multi-Regional Clinical Trials and ICH E17 Webinar recording and presentation materials.
This webinar provides:
- Details about the key statistical considerations of the E17
- A summary of the discussions that took place at the recent ICH meeting in Japan
- Encouragements to engage in discussions with regulatory authorities when planning MRCTs