In its biannual North American meeting this month, the International Council on Harmonization (ICH) said that a third revision of its ICH E6 good clinical practices (GCP) guideline would be released in draft form in December 2021, with additional recommendations for using technologies and methods developed since its last revision in 2016.

The 2016 revision, ICH E6(R2), focused on risk-based decisionmaking, which would remain the overall focus of the revised guideline, the ICH says. But the council plans to address issues that have become prominent during the COVID-19 pandemic, such as trial decentralization, remote monitoring, digital health tools, telemedicine and use of real-world data (RWD).

The new revision will be issued in two phases, which the ICH is calling Annex 1 and Annex 2. Annex 1 will be an “overarching principles and objectives document” covering interventional clinical trials. When complete, it will replace the current E6(R2). Annex 2 will cover nontraditional clinical trials, including pragmatic and decentralized studies, as well as those incorporating RWD. Work on Annex 2 will not begin until the first draft of Annex 1 is released.

Read the ICH E6(R3) concept paper at https://bit.ly/2IBGMkp.