EMA’s reflection paper on patient experience data: A step toward greater patient-centricity

The European Medicines Agency (EMA) has published a new reflection paper on the use of Patient Experience Data (PED) in drug development, regulatory evaluation, and post-market surveillance. This marks a significant effort to formalize patient engagement and ensure that treatments align with patient needs and preferences, particularly through structured patient insights approaches that support regulatory decision-making.

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Key Takeaways for Stakeholders

1. Expanding PED Collection Across the Drug Lifecycle

The reflection paper highlights various sources of PED, such as clinical trial data, real-world evidence (RWE), and safety surveillance systems, emphasizing their importance in informing better drug development, regulatory decisions, and post-market assessments. EMA stresses the need for robust methodologies, including fit-for-purpose patient-reported outcomes (PROs) and qualitative research, which may include structured in-trial patient interviews conducted in compliance with regulatory and ethical standards. The paper also acknowledges challenges such as ensuring data quality, representativeness, and minimizing participant burden.

2. PED’s Role in Regulatory and Market Access Strategies

Incorporating PED has strong implications for benefit-risk assessments and Health Technology Assessments (HTAs). EMA encourages sponsors to include patient insights in clinical trial designs, making therapies more patient-focused, and ultimately improving adherence and real-world outcomes. This perspective aligns with broader discussions on the value of patient interviews in early drug development, where qualitative data can complement traditional clinical endpoints and inform regulatory and market access strategies.

3. Opportunity for Stakeholder Feedback

Importantly, the reflection paper is currently a draft and open for public consultation. EMA invites stakeholders to provide comments via a formal feedback form, which must be submitted by 31 January 2026 to [email protected]. This gives pharmaceutical companies, patient organizations, and other key players a unique opportunity to help shape the final guidelines and ensure their perspectives are considered.

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Why This Matters

For stakeholders in Clinical Development, Regulatory Affairs, HEOR, and Market Access, the reflection paper represents both a challenge and opportunity. By embracing EMA’s evolving framework, companies can meet regulatory expectations, enhance patient-centricity, and strengthen their market propositions. Stakeholders should actively review the draft and utilize the open consultation period to ensure alignment with industry and patient needs.

The full reflection paper can be found here: Patient experience data (PED) reflection paper | European Medicines Agency (EMA)

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