Japan's PMDA Considering Data Monitoring Committee Guidance, Weighs In On Adaptive Design - DIA Japan
This article was originally published in PharmAsia News
Executive Summary
TOKYO - Drug reviewers in Japan do not see as many adaptive trial designs as reviewers in the U.S., and to ensure data integrity for the potentially controversial trials companies should consult with the Pharmaceuticals and Medical Devices Agency as early as possible, an official said, while adding that regulatory guidance may soon be on the way