FDA Publishes Draft ICH E22 Guideline on Patient Preference Studies for Public Consultation
The U.S. Food and Drug Administration (FDA) has released a draft guidance adopting the ICH E22 guideline on General Considerations for Patient Preference Studies (PPS). The document was endorsed by the ICH Assembly on 19 November 2025 and is currently under public consultation.
The guideline aims to harmonise regulatory expectations across ICH regions regarding the design, conduct, analysis, and submission of patient preference studies, particularly in the context of drug development and post-marketing evaluations.
What the ICH E22 guideline covers
ICH E22 provides high-level scientific principles rather than prescriptive methodological requirements. It focuses on stated-preference methods, such as surveys and interviews, where patients are asked to express preferences and acceptable trade-offs between treatment attributes, including efficacy, safety, and other relevant characteristics.
The guideline outlines:
The role of PPS across the product lifecycle, including early development, clinical trial design, benefit–risk assessment, and post-marketing activities;
General principles, such as participant protection, patient involvement in study design, early planning, global applicability, and quality standards;
Practical considerations for study objectives, design, sample selection, analysis plans, and reporting;
Expectations for documentation and submission, including placement of PPS reports within CTD Modules 2 and 5.
Importantly, the FDA clarifies that PPS do not replace clinical efficacy or safety data, but may be considered alongside these data in regulatory decision-making.
Implications for manufacturers
Although the guideline is explicitly focused on medicinal products, it reflects a broader and growing regulatory emphasis on the systematic inclusion of the patient perspective in development and evaluation activities.
For manufacturers, this draft guidance signals that:
Regulators expect early and structured consideration of patient preferences, particularly where benefit–risk trade-offs are complex or uncertain;
PPS must follow robust scientific and quality standards, with clear justification of methods, sample selection, and analysis;
Transparency and documentation are critical, including pre-specified protocols and analysis plans;
Global development programmes may leverage PPS conducted in other regions, provided their applicability is clearly justified.
As the guideline is currently under consultation, manufacturers involved in global development programmes may wish to review their current and planned use of patient preference data to ensure alignment with the principles set out in ICH E22.
Status of the guidance
This is a draft guidance and does not establish legally binding requirements. Stakeholders are encouraged to review the document and consider providing feedback during the public consultation phase.
Once finalised, ICH E22 is expected to represent the FDA’s current thinking on patient preference studies and contribute to greater international harmonisation in this area.
Read the full document below.
