Why Are Patient-Reported Outcomes Becoming Increasingly Important For Medical Affairs?

Why are patient-reported outcomes becoming increasingly important for medical affairs?

Real-world evidence (RWE) has moved from a supporting role in drug development to a strategic pillar across the product lifecycle. As regulators and health technology assessment (HTA) bodies demand more patient-centred evidence, Medical Affairs teams recognise the need to gather insights directly from patients.

In this context, RWE that captures the lived experience behind clinical endpoints, particularly patient-reported outcomes (PROs), is becoming increasingly important. Quality-of-life data, symptom burden, daily functioning and long-term patient experience are now central to HTA and regulatory value assessments. These measures also support value-based or risk-sharing agreements with payers, which are becoming more common.

For these reasons, Medical Affairs teams are seeking robust, patient-centred evidence and often engage patient groups not only for collaboration but also for the generation of high-value patient-reported outcomes data.

Why patient-reported outcomes are becoming essential measures

Randomised controlled trials (RCTs) remain the gold standard, but they cannot fully represent how medicines perform in everyday life. Real-world evidence offers:

• Long-term safety data
•  Effectiveness in routine care
• Adherence and persistence insights
•  Impact on functioning and daily life
• Outcomes that matter most to individuals

These domains reflect the real-world value of a therapy, and HTA bodies are increasingly recognising their importance when determining cost-effectiveness.

A recent example is NICE, which increased its cost-effectiveness threshold from £20k–£30k to £25k–£35k per QALY. While specific to the UK, it reflects a wider global shift: HTA agencies are giving more weight to patient-reported improvements that were previously considered “marginal” such as symptom relief and functional gains. When thresholds rise, these smaller quality-of-life benefits have more room to meaningfully influence outcomes.

Across markets, patient reported outcomes data is therefore moving from optional to essential. For Medical Affairs, this positions patient-derived RWE at the centre of how value is demonstrated and communicated.

How patient organisations help with patient-reported outcomes

Patient organisations have trust within their communities and understand day-to-day challenges in ways that clinical measures alone cannot reflect. They hold a unique position in healthcare ecosystems as they:

1. Provide access to diverse, real-world patient populations
   Unlike clinical trials, patient groups reach individuals across ages, comorbidities, socioeconomic backgrounds and disease stages, offering a more representative evidence base.
2. Support the generation of meaningful PROs
   Patients can report on symptoms, treatment burden, fatigue, mobility, mental health impact and overall quality of life, key elements now recognised as central to value assessment.
3. Enhance study engagement and retention
   Patients involved in co-design feel ownership and are more likely to stay engaged in long-term observational studies.
4. Help shape evidence that is clinically and personally meaningful
   Through co-creation, PAGs ensure outcomes reflect what matters, not simply what is easy to measure.
5. Strengthen the credibility of patient-centred evidence
   Insights from trusted patient organisations are perceived as grounded and reliable by regulators and HTA bodies.

Using the Delphi method to generate patient real-world evidence

While patient-reported outcomes are often captured through surveys, digital questionnaires or patient-support programmes, these approaches can sometimes produce fragmented or inconsistent data, especially when patient experiences vary widely. There is a growing need for methodologies that bring structure, rigour and consensus to patient input.

One method increasingly used by Medical Affairs is the Delphi method, a structured, iterative process designed to build consensus among experts, including patients. Traditionally used for clinical guideline development, Delphi is now recognised as an efficient and transparent way to capture validated patient perspectives and quality-of-life insights. Delphi panels support high-quality patient evidence because they:

1. Capture diverse lived experiences and ensure anonymity
   Panels include patients with different severities, demographics and treatment histories, and anonymity ensures all voices carry equal weight.
2. Identify the outcomes that matter most to patients
   Multiple rounds allow the group to converge on the symptoms, impacts and priorities that are most important to measure in real-world studies.
3. Help validate patient-reported outcomes
   Delphi consensus can confirm whether proposed PRO measures truly reflect the patient experience, strengthening evidence packages for regulators and HTA bodies.
4. Structure insights for quality-of-life measurement
   As HTAs place more emphasis on QoL, structured insight becomes essential. Delphi outputs help define the domains most relevant to QALY gains.
5. Offer practical, efficient and scalable execution
   Online platforms enable rapid turnaround while maintaining methodological rigour.

For Medical Affairs, Delphi bridges a critical gap: it produces evidence that is both patient-centred and methodologically robust, making it ideal for supplementing RWE programmes, post-launch evidence plans and HTA submissions.

Approaches like Delphi enable Medical Affairs to generate evidence that is scientifically credible, patient-centred and aligned with modern regulatory and HTA expectations. This evolution in how evidence is produced and applied positions Medical Affairs as a key driver of patient-focused, real-world insight in the years ahead.

Discover how Triducive can help

Triducive is an expert medical communications agency that generates consensus-led evidence, which is published and supports change in healthcare. Through Delphi consensus studies, Triducive has experience in publishing over 50 manuscripts in peer-reviewed journals. Our team of healthcare experts and scientific writers is ready to provide guidance and support at any stage of the evidence generation process. Contact us for more information about Delphi consensus studies.