Our Services
Our Services
Patient Reported Outcomes
Patient Reported Outcomes
Advising on the strategic selection and use of patient-reported outcome measures.
Advising on the strategic selection and use of patient-reported outcome measures.
Advising on the strategic selection and use of patient-reported outcome measures.
How patients experience a treatment matters as much as its clinical performance; regulators, assessment bodies and payers increasingly expect evidence that captures the patient voice.
Getting the endpoint strategy right at the start determines whether patient experience data can support a label claim, drive an assessment outcome, or both.
How patients experience a treatment matters as much as its clinical performance.
Regulators, assessment bodies and payers increasingly expect evidence that captures the patient voice, but each applies different standards for what they will accept.
Getting the endpoint strategy right at the start determines whether patient experience data can support a label claim, drive an HTA outcome, or both.
The Evidence Landscape
The Evidence Landscape
The Evidence Landscape
54%
54%
54%
of the 45 health technology assessment submissions reviewed across the UK, Germany, France, Italy and Spain between 2020 and 2025 included patient-reported outcome data.
Fazeli et al. ISPOR Europe, 2025.
31%
31%
31%
of pivotal oncology trials behind FDA approvals in 2022 included patient-reported outcomes, up from 5.5% in 2006.
Ojo et al. ASCO Annual Meeting, 2023. Abstract 1569.
How we support you.
How we support you.
How we support you.
We advise on patient-reported outcome strategy from the first choice of measures through to how the results are analysed.
That includes selecting and reviewing instruments, designing and overseeing qualitative research with patients, and planning how and when data is collected.
We work with your teams so that outcome strategy fits the claims you need to support and the wider evidence plan.
We also advise on the analysis approach, covering missing data, meaningful change thresholds and responder definitions.
Qualitative patient experience research, from interview guide development and remote or in-person patient interviews through to concept elicitation, content validity assessment and thematic analysis.
Quantitative patient-reported outcomes analysis planning, including missing data methodology, meaningful change thresholds and responder definitions.
Administration and data collection strategy, including ePRO implementation, BYOD (bring your own device) approaches, assessment timing, frequency and participant burden considerations.
Targeted literature reviews supporting instrument selection, endpoint positioning and regulatory precedent.
Instrument selection, with documented justification against regulatory and assessment requirements.
Review of the validity, reliability and responsiveness evidence for each candidate instrument in the target population.
Design and oversight of qualitative patient experience research, from interview guides and concept elicitation to thematic analysis.
Administration strategy covering electronic data capture, timing, mode, frequency and participant burden.
Instrument selection, with documented justification against regulatory and assessment requirements.
Review of the validity, reliability and responsiveness evidence for each candidate instrument in the target population.
Design and oversight of qualitative patient experience research, from interview guides and concept elicitation to thematic analysis.
Administration strategy covering electronic data capture, timing, mode, frequency and participant burden.
Related Services
Related Services
Related Services
Patient-reported outcome strategy sits alongside study design and protocol development, feeds into scientific communications and publications, and connects to evidence generation planning where endpoint strategy is part of the wider evidence portfolio.
Patient-reported outcome strategy sits alongside study design and protocol development, feeds into scientific communications and publications, and connects to evidence generation planning where endpoint strategy is part of the wider evidence portfolio.
Take Real-World Research Further
If you would like to discuss a programme, please get in touch.