Rewriting the Rules: How to Prepare for ICH E6 (R3)

The International Council for Harmonisation (ICH) establishes industry-wide standards for clinical trials – and those standards are undergoing a complete rewrite, affecting the ways trial data is monitored, analyzed, and de-risked. These changes are being developed both at the behest of and with extensive input from a wide range of industry insiders; and they are explicitly aimed at helping eliminate complexity, enabling sponsors and researchers to take advantage of exciting new technologies and the innovative trial designs they make possible. Yet, changing standards will inevitably require changing processes and procedures to meet those standards; it will pay to be prepared.