How does industry perceive the impact of ICH E17 Multi-Regional Clinical Trial (MRCT) guideline in some key international countries? Are the guideline recommendations fully utilized, and how are regulatory authorities being perceived in implementing them? This article shares the results from a recent industry survey about how implementation of the E17 guideline is progressing in seven countries.
Background: Why Did the E17 Guideline Come About?
In today’s globalized drug development environment, many companies favor MRCTs to generate data that can be accepted by multiple regulatory authorities to support approval of new medicines. As well as reducing unnecessary duplication of studies, MRCTs should reduce drug lag in key markets and improve patient access to new transformative treatments. However, evaluation of data from MRCTs for drug approval can pose a wide range of challenges for regulatory authorities. As a result, work that started in June 2014 at the ICH level to provide harmonized and international guidance on planning and designing MRCTs was finalized in November 2017 with the release of the ICH E17 guideline aimed at increasing MRCT data acceptance by multiple regulatory authorities.
To assess whether the ICH E17 guideline is fully utilised, the European Federation of Pharmaceutical Industry Associations (EFPIA) conducted a survey amongst its member companies to assess perceptions of benefits and barriers to the acceptability of the guideline in key countries: Japan, South Korea, China, Brazil (as ICH Members), and Russia, Saudi Arabia, and India (as ICH Observers). Data were gathered from EFPIA member companies during the summer of 2020.
The survey comprised three sections:
- Section A: to gauge the activity level and awareness or understanding in industry,
- Section B: to gather data on implementation of different aspects of the guideline to guide training and advocacy, and
- Section C: to understand industry views on the benefits of and hurdles to implementation.
The survey readout helped identify key challenges and guide training and advocacy activities to further ICH E17 guideline implementation.