The International Council for Harmonisation (ICH) has adopted Annex 2 of ICH E6(R3), updating international guidance to reflect how clinical trials are increasingly conducted beyond traditional research sites.
Good Clinical Practice (GCP) is the international ethical, scientific and quality standard for clinical trials involving people. Its latest revision, ICH E6(R3), brings together its overarching principles, Annex 1 and Annex 2 in one consolidated guideline.
Annex 2 explains how Good Clinical Practice applies to trials using decentralised activities, pragmatic designs and real-world data. These approaches may include remote consultations, trial procedures at participants’ homes or local health centres, digital health technologies, and data from electronic health records or patient registries.
For people living with rare diseases, such approaches could reduce the need to travel to specialist centres and support research involving small, geographically dispersed populations. They may also help researchers make better use of existing health data when conventional trials are difficult to conduct.
Although the final annex contains no dedicated provisions for rare diseases, it provides a clearer framework for more flexible and participant-centred research while protecting participants’ rights, safety and well-being and the reliability of trial results.
