ICH E6 (R3) Revision Overview

Three decades ago, an international committee came together to create a revolutionary document designed to improve the efficiency of new drug development. Dubbed ICH E6, it has provided consistent guidance for clinical trials around the world. Today, plans are underway to update it for the second time in four years. Why?

The industry is embracing a vast array of emerging technologies: an avalanche of diverse electronic data sources that harness new modes of collection and support innovative trial designs. These technologies bring new opportunities for speed, efficiency, and collection of real-world data to support patient-centric operations. They also demand new risk-based strategies and supporting ecosystem platforms to protect patients, data integrity, and even the broader public health. Yet, the industry is concerned that researchers may not be taking full advantage of these advances because, under ICH E6 (R2) guidelines, they require too much additional paperwork.

In an effort to remove such burdens, the working group is introducing, ICH E6 (R3). Its goal remains consistent with the original version: to maximize efficiencies and facilitate innovations in clinical trials. To succeed, this draft will be flexible enough to adapt to designs and technologies that have not yet been conceived. Focusing more broadly on principles and objectives, including further advancing the concept of risk-based approaches. A major focus will be on Non-Traditional Intervention Clinical Trials.