The International Council for Harmonization (ICH) is inviting stakeholders to participate in the consultation for Annex 2 of the ICH E6(R3) guidelines. This section is specifically designed to address emerging considerations in interventional clinical trials, such as decentralized and pragmatic trials, as well as the integration of real-world data. As clinical trial methodologies evolve, Annex 2 aims to provide guidance that supports innovative and efficient trial designs while ensuring participant safety and data integrity. The consultation phase is a crucial step in refining and finalizing the guidelines to reflect current and future clinical research practices.

https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Annex%202_Step2_DraftGuideline_2024_1024_0.pdf