ICH E22 General Considerations for Patient Preference Studies (Step 2 Draft Guideline)

21st January 2026

The ICH E22 draft guideline establishes a harmonised framework for Patient Preference Studies (PPS) — research that formally captures what matters most to patients (such as trade-offs between benefits and risks or preferences for different treatment attributes). The document provides general principles on the use, design, conduct, analysis and regulatory submission of PPS to support drug development and regulatory decision-making across ICH regions.

Key aspects include:

• Purpose and scope: PPS aim to generate structured insights into patient values and choices that can inform clinical trial design, benefit-risk assessment, endpoint selection and post-marketing considerations. PPS are complementary to traditional clinical efficacy and safety data.

• General principles: The guideline emphasises ethical conduct, participant protection, multidisciplinary expertise and quality standards for PPS, and encourages early planning and integration of patient perspectives into study objectives.

• Design and methodology: Discussions include stated-preference methods such as discrete choice experiments and how to determine sample size, define research questions and select attributes relevant to patients.

• Use in development and regulatory evaluation: PPS results can help identify unmet needs, prioritise endpoints, interpret benefit-risk trade-offs and support submissions to regulators.

The draft guideline does not focus on the placement of PPS data in product labelling (a regional decision) and excludes caregiver or healthcare-professional preference studies.

Consultation: The draft is out for comment as part of the ICH Step 2 public consultation (typically preceding Step 3 endorsement and eventual finalisation).

Public consultation dates:
EC, Europe - Deadline for comments by 12 April 2026
EDA, Egypt - Deadline for comments by 21 February 2026
Health Canada, Canada - Deadline for comments by 16 April 2026
Swissmedic, Switzerland - Deadline for comments by 12 April 20

Link: https://database.ich.org/sites/default/files/ICH_E22_Step2_draftGuideline_Assembly_Endorsed_FINAL_2025_1119.pdf

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