Integrating patient preferences into drug development: the importance of the ICH E22 Guideline

Abstract

Background: Patient perspectives are increasingly recognised as an important component of evidence used in medicinal product development and regulatory decision-making. However, the systematic use of patient preference information has historically been limited by the absence of harmonised methodological standards. To address this gap, the International Council for Harmonisation (ICH) developed the E22 guideline, General Considerations for Patient Preference Studies.
Objective: This paper examines the policy relevance of the ICH E22 guideline and illustrates the growing role of patient preference studies in drug development and regulatory decision-making.
Methods: We analyse the regulatory and methodological framework proposed in ICH E22 and review published examples of patient preference studies conducted across different stages of the product lifecycle.
Results: Patient preference studies are increasingly used to inform product design, clinical trial planning, benefit-risk assessment, and post-marketing evaluation. The ICH E22 guideline establishes a harmonised framework for the design, conduct, analysis, and reporting of such studies, aiming to improve the reliability, transparency, and regulatory relevance of patient preference information.
Conclusion: By providing internationally harmonised methodological guidance, ICH E22 can support the systematic integration of patient perspectives into regulatory science. Its implementation may strengthen patient-centred decision-making and contribute to the development of products that better reflect patient priorities.