ICH E22 Guideline on general considerations for patient preference studies

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Open for consultation from 12 December to 12 April, this draft ICH guideline sets out how to design and submit robust patient preference studies to inform regulatory decision‑making across a medicine’s lifecycle.

This harmonised draft guideline explains how patient preference studies (PPS) can be designed, conducted, analysed and submitted to support drug development and regulatory evaluation, including benefit–risk assessment and maintenance of approvals. It clarifies that PPS generate structured insights into what matters most to patients when weighing treatment attributes such as outcomes, risks and other relevant characteristics, and provides general methodological considerations intended to improve the quality and usability of patient preference information in regulatory contexts.

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Year of publication

2025

Source

European Medicines Agency (EMA)

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