Who Gets to Define the PICO? Why Patient and Clinician Input
Matters for EU JCA Evidence Planning
A treatment may perform well in a clinical trial. But does the evidence answer the questions that matter to patients, clinicians and HTA assessors across Europe?
That question is becoming harder to leave until submission. On 14 September 2026, the European Commission published three templates to support written input from patients, carers and clinicians in the Joint Clinical Assessment (JCA) process. Two support input during JCA scoping; the third allows these groups to comment on the assessment report.
The templates do not give any one group control over the final PICO or create a new requirement for a particular study. They do, however, provide a timely prompt for pharmaceutical and biopharmaceutical companies: have we tested our evidence plan against the treatment experience and clinical decisions that others may bring into the assessment?
A PICO can be technically sound and still leave a practical question unanswered
PICO describes the population, intervention, comparator and outcomes used to frame a clinical evidence question. Each part carries assumptions.
Consider an oncology treatment evaluated against the comparator selected when a pivotal trial began. By the time the product reaches assessment, clinicians may be using a different sequence of treatments. Patients may also place particular value on avoiding hospital visits or maintaining day-to-day function, while the trial’s strongest results concern another endpoint.
Those observations do not automatically make the trial irrelevant. They identify questions the evidence team must be ready to address:
- Does the trial population reflect the patients likely to receive the treatment?
- How does the trial comparator relate to current clinical practice?
- Are outcomes that matter to patients measured and reported adequately?
- Where the evidence is indirect, what can be concluded with confidence, and what remains uncertain?
The EU JCA provides a scientific analysis of clinical evidence on the relative effects of a health technology. Its work supports national HTA processes, where further access and reimbursement decisions take place.
What the new templates bring into focus
The Commission describes separate scoping templates for patients and carers and for clinical experts, plus a form through which patients, carers and clinicians can comment on the JCA report.
Their publication should encourage evidence teams to examine three issues early.
1. The population described in the dossier
Eligibility criteria help make a trial interpretable, but they may exclude people who are common in routine care. If those differences could affect treatment results, the evidence plan should explain them clearly. Relevant real-world data may help describe the wider patient population, provided the data are suitable for the question being asked.
2. The comparator used in practice
A comparator is more than a line in a submission table. Treatment sequences, availability and clinical choices can differ across health systems. Clinical input can help teams identify where a direct comparison remains relevant and where an indirect comparison or additional analysis may be needed.
3. The outcomes used to describe value
Survival and other clinical endpoints are central in many assessments. Patients may also describe effects on symptoms, function, treatment burden or quality of life that deserve careful measurement. Teams should examine whether their studies capture these outcomes, how complete the data are and what claims the results can support.
These are questions for rigorous evidence planning. Patient experience can reveal a gap; it does not, by itself, quantify a treatment effect or resolve uncertainty.
Where RWE can help and where it cannot
Real-world evidence can make an important contribution when a trial and the expected treatment setting do not line up neatly. Depending on the decision question and the quality of available data, it may help describe treatment pathways, patient characteristics, outcome patterns or the use of comparators in routine care.
The first step is to define which uncertainty the RWE study is meant to address. A database may contain thousands of patients yet still lack the clinical detail, follow-up or outcome measures needed for a particular PICO.
Market Access, HEOR, RWE, Medical Affairs and clinical teams should therefore work from a shared question:
If patients or clinicians describe a different pathway, comparator or meaningful outcome, what evidence would we need to assess its effect on our conclusions?
That question can guide data-source assessment, study design and sensitivity analyses well before a dossier is due. It also helps teams distinguish between an issue they can investigate and one they must communicate as a limitation.
A practical check for evidence teams
Before finalising an EU JCA evidence plan, teams can ask:
- Population: Which patients are under-represented in the pivotal evidence, and could that change how results are interpreted?
- Comparator: Does the chosen comparison reflect current treatment decisions across the settings relevant to the assessment?
- Outcomes: Are clinically important and patient-relevant outcomes measured with sufficient quality?
- RWE: Can available data answer a defined evidence gap, or would the proposed analysis introduce substantial new uncertainty?
- National access: Which questions may still need to be addressed after the EU-level clinical assessment?
Joint scientific consultations offer developers an opportunity to discuss evidence needs while planning clinical studies for a subsequent JCA. The current 2026 request period runs from 23 September to 21 October, making early evidence planning especially timely for eligible developers.
From patient voice to an evidence strategy
The useful question is not whether a submission mentions patient centricity. It is whether input about lived experience and clinical practice has helped the team identify the right evidence questions, and whether its analyses can answer them responsibly.
The newly published templates make patient, carer and clinician input more visible at defined points in the JCA process. For evidence teams, the opportunity is to examine those perspectives early, test assumptions behind the PICO and explain uncertainty openly. That is how a clinical evidence package becomes more useful to the people assessing it and, ultimately, to those making access decisions.
Continue the technical discussion in Amsterdam
Continue the discussion in Amsterdam: The European RWE & Market Access Summit 2026: JCA & PICO Strategy Edition takes place on 21–22 October 2026 at Inntel Hotels Amsterdam Landmark. Join leaders in RWE, HEOR, HTA and Market Access to examine how evidence planning connects to patient value and access decisions.
View the European RWE & Market Access Summit
Join senior professionals from pharmaceutical and biotechnology companies, HTA bodies, payer organisations, consultancies, data partners and evidence-solution providers to examine how Europe’s new assessment environment is changing evidence generation and access strategy.