n December 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published the draft scientific guideline E22 on general considerations for patient preference studies for stakeholder review and feedback. It is widely acknowledged that input from patients, as users of medicines, can inform medicines development, enhance regulatory decision-making, and result in outcomes more relevant to patient interests. The draft ICH E22 Guideline is open for public consultation until April 12, 2026. It is now time to read, reflect upon, and respond to the proposed text.

As outlined by a recent draft reflection paper from EMA, patient preference studies (PPS) are one of three important pillars for generating meaningful patient engagement data and should be incorporated into healthcare decision-making. The ICH E22 Guidance is expected to inform stakeholders and researchers about the use, design, conduct, analysis, and submission of PPS aimed at informing drug development, regulatory submission and evaluation, and drug approvals and maintenance of such approvals.

PPS aim to assess the relative desirability or acceptability of health interventions, their proposed characteristics, and/or intended outcomes. PPS can generate structured insights about the relative importance of characteristics (also referred to as attributes) that are considered by patients when making treatment decisions. Such attributes may include, for example, efficacy or safety outcomes or any other potentially relevant characteristics.

The ICH guideline has been developed in response to stakeholder requests for a harmonized approach that supports generation of PPS in global drug development and enhances predictability on usefulness of the data in global healthcare decision-making.

Incorporating patient perspectives has become more systematic throughout drug development to better align decisions with patients’ values and needs, and in the benefit-risk assessment, as reflected in ICH M4E(R2) and the ICH Periodic Benefit-Risk Evaluation Report (PBRER) E2C(R2). Patient preference research is a large and evolving field, and basic guidance has been made available by several institutions. Relevant examples of available technical documents that have informed the guidance development include the US FDA Guidance on Patient Preference Information, the IMI PREFER Recommendations and the EMA Qualification Opinion of IMI PREFER, the Medical Device Innovation Consortium (MDIC) Patient-Centered Benefit-Risk Framework, and the Professional Society for Health Economics and Outcomes Research (ISPOR) best practice documents on Patient Preference Methods and Quantitative Benefit-Risk Assessment, as well as the Council for International Organizations of Medical Sciences (CIOMS) guidelines XI and XII (Benefit-Risk Balance for Medicinal Products and Patient Involvement in the Development, Regulation, and Safe Use of Medicines).

The draft ICH E22 Guidance includes sections on general principles of PPS and its role in drug development and post-marketing evaluations. It also provides recommendations and practical considerations on study conduct and analysis as well as reporting and submission to Common Technical Documents (CTDs) for marketing authorization applications.

Why is This ICH Guidance on PPS Important?

Understanding qualitative and quantitative insights into patient preferences can influence identifying unmet needs, designing clinical studies that better align with patients’ wants and needs, interpreting the importance of results (or lack thereof), and other aspects of drug development. PPS may be particularly valuable when seeking to understand how patients perceive and prioritize potential treatment outcomes and other characteristics, and patient views on different specific aspects of their condition. Patients who experience a disease or utilize particular treatment modalities can provide relevant perspectives on the disease outcomes and effects of drugs and other health interventions. For diagnostic or preventive programs, or possible future treatments, healthy and at-risk individuals may also contribute informed and informative perspectives.

While the information provided by PPS does not replace the information provided by efficacy and safety studies, PPS information may be useful across the different phases of drug development, from pre- through post-marketing. As described in ICH guideline documents M4E(R2) and E2C(R2), it may also be considered together with efficacy and safety information in the benefit-risk assessment of drugs and related regulatory decisions.

Stakeholders anticipate that these guidance documents, taken together, will foster the use of PPS in drug development and allow a greater impact of the patient voice in drug development and healthcare decision-making—a shared aspiration of many. The development of the ICH E22 guideline on PPS is a helpful step in bringing such studies into more routine use during global drug development.

How Can You Get Involved in Shaping the ICH Guideline to Promote Use of Patient Preference Studies?

If you are interested in supporting the development of such a systematic approach to better incorporating patient voices, you can respond to the ICH E22 call for comment. While there is an option to provide comments directly to the ICH Secretariat (deadline April 12, 2026), stakeholders from ICH Member countries/regions are encouraged to submit their comments via their respective Regulatory Authorities. At the time of this article’s publication, the draft has been published by:

• European Commission (via EMA): Deadline for comments 12 April 2026
• EDA, Egypt: Deadline for comments 21 February 2026
• Swissmedic, Switzerland: Deadline for comments 12 April 2026.

Other regulators will soon publish the draft for comment on their websites. Comments from all sources will then be considered by the ICH Secretariat drafting group, and a revised version of the guideline will be prepared for regulators to refine for agreement.

In addition, it is important to actively support individual patient preference research to broaden its systematic use:

• Developers of new therapies: Collect and document PPS to identify and develop therapies that truly matter to patients; share PPS in your briefing books, regulatory dossiers, and interactions with regulatory authorities; and add it to the product label when relevant.
• Patient experts or patient organizations: Contribute to PPS, collect learnings from PPS, and/or conduct systematic PPS, and share them with healthcare decision makers to emphasize the premise that the patient voice must be heard loud and clear.
• Patient preference study researchers: Seek early regulatory alignment and publish your results to foster development of this research area and its impact on healthcare decision-making. Of note, the PREFER EXPERT NETWORK is a voluntary network of pharmaceutical companies, academic institutions, consultants, and patient representatives devoted to promoting the development and adoption of patient preferences in decision-making about medical products.