Sep 25
ICH-E6(R3) represents a shift in mindset when it comes to clinical trials. Rather than trying to control every part of a trial equally, the guideline wants researchers to focus most on factors that are critical to participant safety and the reliability of trial results. It introduces the idea of “proportionality,” meaning more control is applied to high-risk areas. It also acknowledges that technology plays a major role in today’s research, and outlines expectations for using digital systems responsibly.
Read the full article by The Medicine Maker here.
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