When the European Medicines Agency (EMA) released its Reflection Paper on Patient Experience Data (PED) in September 2025, it marked a significant milestone in Europe’s shift toward structured, decision‑relevant patient input. For those of us working daily with sponsors to design and deliver PED strategies, the paper represents both progress and possibility: progress in recognizing the value of patient perspectives, and possibility in how the field can evolve toward more clarity, consistency, and global alignment.

At IQVIA, our Patient Centered Solutions team works across the development lifecycle to generate scientifically robust, patient‑centered evidence. As part of that mission, we provided detailed comments on the EMA’s reflection paper. Here, I want to highlight several themes from our perspective, not as critiques, but as opportunities to strengthen a framework that will shape how PED drives regulatory decisions for years to come.

Understanding the Breadth of Patient Experience Data

One of the most notable additions we hope to see in future EMA work is a broader acknowledgment of the full clinical outcome assessment (COA) ecosystem that contributes to patient experience. The current reflection paper places strong emphasis on patient‑reported outcomes, which are central to understanding symptoms, impacts, and quality of life. Yet many patient populations cannot self‑report. Observer‑reported outcomes for pediatric or cognitively impaired populations, clinician‑reported outcomes for complex symptoms, and performance outcomes that capture functional abilities are all essential for building a complete, patient‑centered evidence base.

Bringing these COA types into the PED narrative does more than tidy up a taxonomy. It ensures that all patients, including those least able to advocate for themselves, are represented in regulatory‑grade data, and it helps sponsors design endpoint strategies that align with real‑world disease experience. Just as importantly, clearer scope and terminology, including consistent use of the COA taxonomy and plain definitions for concepts such as ‘meaningful change thresholds’ (e.g., within‑patient change vs between‑group differences) will help sponsors interpret what EMA expects now, and what may become best practice as guidance evolves.

Connecting PED to the European Health Technology Assessment (EU HTA) and Joint Clinical Assessment (JCA)

Another key area for clarity lies in the relationship between PED and the evolving European health technology assessment (HTA) landscape. With the Joint Clinical Assessment (JCA) process now taking shape under the EU HTA Regulation, sponsors need to know how PED can and should inform both regulatory and HTA submissions. The reflection paper does not yet provide explicit guidance on this connection. But clear expectations would help sponsors avoid duplicative efforts and ensure PED can meaningfully support patient‑relevant endpoints, preference‑sensitive benefit–risk trade‑offs, and assessments of meaningful change across both regulatory and HTA pathways. As Europe moves toward more integrated evidence evaluation, this alignment becomes not just beneficial but essential.

Strengthening Definitions and Evidentiary Roles

The reflection paper also introduces concepts, such as “minimum relevant thresholds for patients,” that would benefit from clearer definitions. Sponsors need to understand how regulators interpret concepts like meaningful change, threshold setting, and the role of interpretation in qualitative research.

PED is not monolithic; it can serve exploratory purposes, inform decision‑making, or directly support regulatory conclusions. Clarifying these evidentiary roles would help sponsors match methodological rigor to the context of use, an approach reflected in other established frameworks (such as the FDA’s Patient‑Focused Drug Development guidance series and the IMI‑PREFER recommendations).

Elevating Patient Preference Studies Through Global Alignment

We were pleased to see strong recognition of patient preference studies (PPS), a field that has matured considerably over the past decade. Still, the reflection paper would be stronger with explicit reference to existing international frameworks, including ICH E22 and IMI‑PREFER, as well as the substantial experience from medical device regulation where PPS are already influencing benefit–risk decisions. Anchoring EMA’s views to these established frameworks will not only support methodological consistency but also help sponsors design preference studies that are fit for regulatory purposes in a global evidence ecosystem.

Bringing Qualitative Methods and Early-Phase PED Into Focus

Qualitative insights, whether through concept elicitation, in‑trial interviews, or longitudinal qualitative follow‑up, are critical for understanding evolving patient needs, treatment burden, and reasons for continuation or discontinuation. The reflection paper acknowledges qualitative work but could provide stronger direction on how qualitative PED should be incorporated into early development. Early‑phase assessment of COAs, for example, helps ensure that instruments are feasible, relevant, and appropriately understood long before confirmatory Phase 3 trials. This not only improves data quality but also reduces the risk of late‑stage surprises that could derail endpoint strategies. Recognizing qualitative methods as equally valuable in well‑researched diseases, not only in areas of unmet knowledge, would further strengthen the field.

Ensuring Real‑World PED Meets Regulatory Expectations

As non‑interventional and real‑world studies become more central to development plans, sponsors increasingly ask what constitutes acceptable real‑world PED for regulatory decisions. The reflection paper introduces the topic but stops short of defining clear quality expectations. Providing guidance on minimum methodological rigor, pathways for scientific advice, and whether real‑world PED can support labeling claims would give sponsors confidence in designing real‑world evidence strategies that meaningfully complement clinical trial data. More broadly, it helps to reinforce that data quality is driven by more than the collection mode: clear objectives, fit‑for‑purpose methods, appropriate sampling, instrument design, cultural and linguistic considerations, and robust quality checks all influence whether PED is reliable and decision‑ready.

Looking Ahead: Opportunities for Alignment and Innovation

The EMA’s reflection paper is an important step in defining expectations for PED. But as PED becomes increasingly central to decision‑making, sponsors benefit from clear definitions, global alignment, and practical guidance on evidence planning.

At IQVIA, we stand ready to support sponsors through this next phase. With deep expertise in COA science, qualitative research, patient preference studies, and integrated regulatory strategy, we help organizations build PED programs that reflect the lived experiences of patients and meet the evolving expectations of regulators worldwide.

The reflection paper opens the door to more consistent, transparent, and patient‑aligned evidence generation. Now is the moment for industry, regulators, and patient communities to work together to realize that promise.

Learn more about IQVIA’s PCS team here, or contact us.