IMI PREFER Framework and Recommendations
The IMI PREFER Framework provides guidance on how to include patient preferences in decisions about medicinal products, especially during regulatory evaluation. It helps ensure that what matters most to patients—like treatment benefits, risks, and trade-offs—is clearly understood and used by regulators and developers.
At a glance
Use when
Informing regulatory submissions with patient perspectives,Designing patient preference studies for regulatory use,Seeking scientific advice involving patient input,Enhancing patient-centered benefit-risk assessment
Avoid when
When patient preferences are not relevant to the decision context,When methodological quality of PPS cannot be ensured,When regulatory pathways do not support patient preference data submission
Inputs
Design and results of patient preference studies (PPS), stakeholder input (regulators, patients, industry, HTA bodies)
Outputs
Guidance on integrating patient preferences into regulatory evaluation, recommendations for PPS design and consultation, strategies for PPS communication in regulatory documents
How it works
The IMI PREFER Framework and Recommendations result from a six-year European public-private partnership that conducted literature reviews, interviews, and focus groups with stakeholders including regulators, patients, industry, and HTA bodies. It offers evidence-based guidance on the use of Patient Preference Studies (PPS) in regulatory decision-making, covering applications in benefit-risk assessment, scientific advice, endpoint selection, and communication of patient-relevant outcomes in regulatory documents such as the European Public Assessment Report (EPAR) and Summary of Product Characteristics (SmPC). The framework addresses methodological standards, stakeholder consultation processes, and operational challenges in integrating PPS into regulatory workflows.
- HTA domains
- Patient and Social Aspects
- Assumptions
- Patient preferences can be reliably elicited and are relevant to regulatory decision-making; stakeholders are willing to incorporate patient perspectives; high-quality PPS can be designed and conducted with appropriate methodological rigor
- Strengths
- Developed through extensive stakeholder engagement including regulators and patients; evidence-based through literature reviews and qualitative research; addresses practical and methodological aspects of PPS use in regulation; promotes patient-centered drug development
- Limitations
- Lack of real-world case studies demonstrating impact on regulatory decisions; unresolved questions about funding, timing, and independence of PPS; limited incentives and formalized processes for PPS submission in regulatory pathways
- Also known as
- PREFER, IMI PREFER, PREFER recommendations
Questions this answers
- › How can patient preferences inform regulatory decisions about medicinal products?
- › When and how should developers consult regulators about patient preference studies?
- › How can patient preference data be communicated in regulatory documents?
- › What are the barriers to using patient preference studies in regulatory evaluation?
- › What methodological considerations are important for designing valid patient preference studies?
- › How can patient-relevant endpoints and trade-offs be identified and incorporated into regulatory assessments?
References & sources
Similar by meaning
Beta record. Generated from the primary source via AI extraction and independent audit, pending final human review.