In pharmaceutical R&D, claims data and electronic health records (EHR) have long been core sources of real-world data. They are essential for understanding diagnoses, procedures, and treatment patterns at scale. But they only tell part of the story.
If you want a complete view of how patients experience disease and treatment in everyday life, you need patient-reported outcomes (PROs). These are the direct reports from patients about their symptoms, functioning, and quality of life, captured in their own words.
At Inspire, we see every day how PROs can transform real-world data by adding nuance, context, and meaning. Below is why PROs matter, and how you can use them to strengthen both R&D and market access efforts.
1. The Limitations of Claims and EHR Data
Claims and EHR data are powerful, but they have clear limitations when you try to understand real-world experiences.
They often:
Lack context. They document what happened, such as a diagnosis code or prescription fill, not why it happened or how it affected the person.
Miss key details. Symptom severity, daily functioning, and emotional impact rarely appear in structured fields.
Act as lagging indicators. These sources are largely retrospective and may not reflect emerging issues or early shifts in patient behavior.
For example, claims might show that a patient filled a prescription three times, then stopped. The data does not explain whether they discontinued due to side effects, cost, difficulty using the product, or a lack of perceived benefit.
Real-world data built only on claims and EHR is informative, but incomplete.
2. The Power of Patient-Reported Outcomes
Patient-reported outcomes fill the gaps by capturing how patients actually feel and function. PROs reflect the lived experience, not just clinical events.
They help you:
Understand the full journey. PROs reveal symptoms, treatment burdens, and day-to-day challenges that are invisible in claims and EHR.
Identify unmet needs. Patient reports can uncover side effects, access barriers, and quality-of-life issues that signal opportunities for better support or new interventions.
Measure what matters to patients. Outcomes such as fatigue, pain interference, social functioning, or treatment satisfaction often drive adherence and long-term success.
Consider multiple sclerosis. Clinical data may focus on relapse rates or MRI findings. PROs often reveal that fatigue, cognitive issues, or mood changes are what truly limit daily life.
Claims and EHR data capture what happened. Patient-reported outcomes explain why it mattered.
Claims and EHR data capture what happened—PROs explain why it mattered.
3. How PROs Strength Real-World Data
When you integrate PROs with traditional data sources, you move from a transactional record toward a holistic view of real-world health.
PROs can:
Complement claims and EHR. You can link quantitative utilization data with qualitative reports on symptoms, functioning, and satisfaction.
Inform trial design and endpoints. PROs highlight the outcomes that matter most to patients, helping teams prioritize endpoints and refine inclusion criteria.
Support regulatory and HTA discussions. Regulators and health technology assessment bodies increasingly expect evidence that reflects patient-centered outcomes.
For instance, if people with diabetes report that a new injectable therapy is difficult or painful to use, that may affect persistence even if glycemic control looks strong on lab values. Those insights can guide improvements in formulation, device design, or patient support programs.
In short, real-world data gains depth and relevance when it includes patient-reported outcomes, not just codes and encounters.
4. Using PROs for Market Access and Value Stories
Patient-reported outcomes are also a critical asset for market access, payer engagement, and value demonstration.
They allow you to:
Show real-world impact. You can demonstrate how a product improves symptoms, functioning, or quality of life beyond traditional clinical endpoints.
Support value-based arrangements. PROs help quantify benefits that matter to patients, which can reinforce pricing and reimbursement discussions.
Build trust with stakeholders. When you incorporate the patient perspective into value stories, you signal that your decisions are grounded in real experiences, not only models.
If asthma patients report fewer nighttime awakenings, greater confidence in disease control, and better ability to participate in daily activities after starting a new inhaler, those PROs support a much richer value narrative than utilization and spirometry alone.
5. How Inspire Delivers Patient-Reported Outcomes
Inspire’s platform brings together millions of patients in condition-specific communities, giving life sciences partners access to real-time, actionable PROs that enhance real-world data strategies.
We help teams:
Collect PROs at scale. Engage patients in surveys, diaries, and longitudinal research that capture symptoms, functioning, and treatment experiences.
Link PROs with other data sources. Combine patient-reported outcomes with claims, EHR, or other real-world data where appropriate, creating a more complete view of the patient journey.
Analyze and interpret. Use advanced analytics to identify trends, patient segments, and patterns that inform both clinical and commercial decisions.
Design targeted research. Run custom studies, focus groups, or interviews to answer precise questions about burden of illness, treatment trade-offs, or support needs.
For example, a pharma team developing a new rheumatoid arthritis therapy might use Inspire to track PROs on pain, stiffness, fatigue, and daily functioning, then link those outcomes with information about treatment persistence and switching behavior.
Conclusion
Patient-reported outcomes are a critical, often underused component of real-world data. By capturing the unfiltered experiences of patients, PROs help you:
Reveal the “why” behind what you see in claims and EHR
Design more patient-centered trials and products
Strengthen evidence packages for regulators and payers
Build strategies that are aligned with real lives, not only clinical measures
When PROs sit alongside traditional real-world data sources, your view of the patient journey becomes more accurate and actionable.