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.
Related Blog Posts
A Toolkit for ICH-E6(R3)
Released at the start of 2025, the ICH-E6(R3) guideline is an updated international standard for how clinical trials should be designed, conducted, recorded, and reported. At its core, the guideline ensures that people who participate in clinical trials are kept safe and that the data collected is reliable and meaningful. This guideline is not a…
Are Pragmatic Trials The Patient Recruitment Solution We’ve Been Looking For?
The age-old problem for clinical research has been the ability to recruit patients. Many clinical research professionals have tried to crack this nut, whether with technology or partnerships or both. Let’s not forget the height of DCTs during the pandemic, which served their purpose but appear to have lost luster in the last few years.…
Solving the Clinical Trial Data Problem
In a new LinkedIn article, Janice Chang, CEO of TransCelerate, and Nicholas Brooke, CEO of The Synergist & PFMD, outline how efforts like the Clinical Trial Data Network, supported by TransCelerate through technical expertise and industry-vetted solutions from our Digital Data Flow initiative, aim to make clinical trial information more structured, connected, and accessible across…