EMA pressed for clearer guidance on decentralized trials

30 May 2025

Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice.

The recommendations follow a public consultation on the International Council for Harmonisation’s (ICH) proposal, which aims to modernize guidance for clinical trials involving decentralized elements, real-world data, and other innovative approaches.

The so-called annex, released in draft form in November, generated comments from more than two dozen organizations across Europe.

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