Patient Experience Data: What is it and why is it important?
Posted on: Tuesday 28 April 2026
In recent years there has been an explosion of interest in patient experience data (PED).
Whilst historically medicine development programmes have met the requirements of quality, safety, and efficacy, there is a recognition now amongst regulators and medicine developers that patients are in the unique position of being able to provide information on the lived experience of their illness and the impact of treatments.
This valuable information can be provided across the whole lifecycle of medicines development, informing regulatory and HTA decision-making as well as pricing and reimbursement.
The European Medicines Agency (EMA) recently drafted a reflection paper on PED which went out to the public for consultation. This reflection paper will complement the ICH 22 guidance General Considerations for Patient Preference Studies which also recently went out for public consultation.
FPM welcomes these initiatives and has provided comment on both papers via its Patient Partnership Forum.
What is Patient Experience Data?
PED is data that is collected directly from patients, (and where relevant, their carers and families) who have lived experience of managing their disease. It captures their perspectives, needs, and preferences.
PED falls into three categories:
1. Patient Reported Outcomes (PROs)
PROs are health outcomes that directly report patients’ experience of their health status. Typically, they capture patient-relevant disease and/or treatment outcomes, including symptoms, physical and cognitive capacity and function, symptomatic adverse events and their tolerability, and health-related quality of life. Ideally PROs should be co-developed with patients rather than by investigators or clinicians alone.
2. Patient Preference Studies (PPS)
PPS assess the desirability or acceptability of a specific option or choice of options relating to a given health intervention (i.e., medicine, treatment, or health devices). Patients are asked to consider the trade-offs of the benefits and risks of each option, measuring how well they align their needs and whether they will provide the benefits they are seeking.
3. Data obtained through patient engagement activities
This is data collected from interactions with patients about their experience with a disease and their preferences regarding treatments and outcomes. It can provide insights on a broad range of topics such as how patients experience their condition, symptoms, burden of disease, burden of treatment, quality of life and treatment preferences.
What are the purposes of the EMA reflection paper and the ICH 22 guidance?
PED and patient preference research are evolving fields.
The EMA reflection paper was developed in response to stakeholders asking for EMA and EMA Committee for Medicinal Products for Human Use guidance on PED at a Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making that was instigated by the EMA in September 2022.
Its purpose is to encourage systematic consideration of PED in medicine development programmes and regulatory submissions. It describes general principles on the use of PED across the lifecycle of medicinal products and identifies types of PED and the main sources of PED. Of note it acknowledges AI tools, social media, and mobile health technologies may all play a role in the generation of PED.
The purpose of the ICH 22 guidance is to outline general considerations about the use, design, conduct, analysis, and submission of PPS aimed at informing drug development, regulatory submission and evaluation, drug approvals, and maintenance of such approvals.
The first EMA consultation period ended on 31 January 2026 (the second is due to close mid-April) and there has been a substantive response. 112 stakeholders commented, including 37 from industry, and more than 2000 comments were received.
This consultation should provide greater clarity for the pharmaceutical industry on the EMA’s expectations in this evolving field.
We believe this is a major step forward in recognising the importance of patients’ perspectives in medicines development and encourage the industry to incorporate this into routine practice.