As a follow-up to the November 2025 endorsement and publication of the ICH E22 draft Guideline on General Considerations for Patient Preference Studies, the E22 Expert Working Group has issued an informational presentation and training materials.<\/p>\n
Patient preference studies ask patients what matters most to them about drugs and other health interventions, such as effectiveness, side effects, safety outcomes, convenience and other factors. These studies help drug developers and regulatory authorities to understand and consider medical needs from the perspective of patients.<\/p>\n
The E22 draft Guideline covers general principles, information on different types of patient preference studies, and recommendations and practical considerations for designing and conducting these studies. Patient preference studies are used today but not everywhere and not consistently. The E22 draft Guideline aims to further harmonise approaches to these studies for regulatory authorities and the pharmaceutical industry in different countries and support the routine inclusion of patient preferences in decision-making.<\/p>\n
This concludes the E22 Expert Working Group\u2019s work on Step 2 of the Guideline development process. The E22 draft Guideline is now at Step 3, the public consultation phase.<\/p>\n