ICH E17-GL is the global guideline for designing multi-regional clinical trials (MRCTs), which allow patient recruitment across multiple countries in a single, unified trial.
The main objective is to create globally acceptable data packages that meet regulatory needs in multiple regions, avoiding duplicate studies.
Core principles include:
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Planning trial design with all target regions in mind from the start
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Ensuring adequate sample sizes from each region, including Japan
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Considering possible ethnic differences in drug response
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Maintaining consistent protocols across all participating countries
For Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) emphasizes the need for meaningful inclusion of Japanese patients to minimize the need for additional bridging studies.
Why it’s important: By following ICH E17, sponsors can accelerate approvals, reduce costs, and streamline global submissions.
Freyr’s support includes: MRCT planning, Japanese patient inclusion strategy, PMDA liaison, and preparation of globally compliant trial data.
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