As pressure on clinical development costs continues to grow, the challenge is no longer simply generating patient experience data (PED) but demonstrating its value. At a recent IQVIA Patient-Centered Solutions Industry Forum in London, industry leaders came together to explore how PED can deliver measurable impact across development, regulatory, and commercial decision-making, and where the field must evolve next.

Across three interactive sessions, discussions focused on return on investment (ROI), the growing role of artificial intelligence (AI), and the expanding use of in-trial interviews (ITIs). Together, these discussions highlighted a shared recognition: while PED is widely accepted as important, measuring its tangible impact in concrete value terms remains a work in progress.

Rethinking ROI: Beyond the Label

Much of the discussion centered on a fundamental challenge: how to demonstrate the ROI of PED in a way that resonates with internal biopharma stakeholders.

Three approaches to demonstrating value were highlighted:

• External expectations (e.g. regulatory guidance and stakeholder demand)
• Demonstrated impact (e.g. case studies, labeling outcomes)
• Quantified ROI (e.g. financial or market impact)

While each of these approaches plays an important role, each has limitations. External expectations are valuable for ensuring ongoing investment and alignment with stakeholder priorities but may be less persuasive when budgets are constrained. Case studies provide compelling examples of impact but can be difficult to generalize across therapeutic areas and are often shaped by hindsight. Quantified ROI is often seen as the most compelling form of evidence, but remains challenging to establish, with limited examples to date and inherent delays in linking PED to long-term outcomes.

As a result, discussions highlighted the need for a more balanced approach, drawing on all three types of evidence and exploring additional leading indicators of value, such as product perception or stakeholder confidence. Together, these perspectives reinforce that demonstrating value is not about identifying a single metric, but about building a broader picture of impact.

Importantly, discussions also highlighted that value is not created through data generation alone, but through how PED are understood, communicated, and used in practice. Across multiple examples shared during the sessions, participants highlighted several barriers that can limit the impact of PED in practice:

• Sales and medical field teams may lack confidence in interpreting or communicating patient-reported outcome (PRO) data
• Healthcare professionals may view it as subjective or difficult to apply in practice
• Patients expressed interest in PED insights, but rarely come across them in clinical practice

Participants also highlighted how difficult it is to isolate the contribution of PED to commercial outcomes such as reimbursed price or sales volume, given limited market data and the many factors that influence product performance.

Some markets, however, provide greater visibility into how evidence is assessed. In Germany, where health technology assessment (HTA) evaluations and pricing decisions are more transparent, PED, particularly PRO evidence, is explicitly reviewed as part of the benefit assessment. Analyses presented during the session showed that positive PRO results are associated with improved HTA outcomes, which can in turn influence pricing decisions and product revenue.

In this context, it was noted that the financial impact observed in Germany alone may be sufficient to offset the investment required to generate PRO data. At the same time, participants highlighted that similar analyses are more challenging in other markets, where the contribution of PED is less clearly defined and more difficult to quantify.

Overall, these insights highlight both the potential value of PED and the challenges in consistently demonstrating ROI, reinforcing the need for complementary approaches to capturing value across different contexts.

AI in Patient-Centered Research: Promise and Pragmatism

The second session explored how AI is beginning to reshape patient-centered research.

AI is already being applied in an experimental manner in areas such as:

• Literature reviews and evidence synthesis
• Qualitative data analysis and coding
• Study design and instrument development
• Patient identification and real-world data integration

Across these applications, discussions highlighted a consistent implementation approach, with AI deployed within structured workflows, supported by human oversight and clear documentation to ensure transparency, reproducibility, and appropriate use.

For example, an AI‑enabled literature review tool demonstrated during the session applied a stepwise, agent‑based process. Each stage of the review was supported by AI and guided by human user input. The process also incorporated curated data sources and deterministic search methods to minimize bias and inconsistency. Embedded documentation created a clear audit trail, supporting transparency and consistent application in practice.

In this context, its potential lies in addressing long-standing challenges such as:

• Processing large, qualitative datasets
• Improving scalability and efficiency
• Accelerating insight generation

However, discussions emphasized the need for a measured and responsible approach:

• Validation and documentation of fit-for-purpose use are essential
• Transparency and explainability must be maintained
• Human oversight remains critical

A clear takeaway was that AI is not replacing scientific judgment; it is augmenting it.

Beyond evidence synthesis, discussions also highlighted opportunities for more creative applications to improve how PED are communicated and used. Patient interview data were consistently described as rich but often underutilized, particularly due to challenges in translating complex qualitative insights into formats that are accessible and useful for different audiences, including patients, healthcare professionals, and other decision-makers.

To address this, examples were presented of more engaging communication approaches, including the use of visual and multimedia formats to present qualitative findings in ways that are easier to understand and apply. These included transforming PED into tailored outputs for different audiences, as well as the use of AI-enabled patient avatars to present aggregated experiences in a more engaging and memorable way. These approaches are being explored in areas such as informed consent forms, where AI and multimedia are used to translate complex, text‑heavy materials into more accessible formats, improving patient understanding while retaining human oversight.

Together, these approaches aim to improve the accessibility and practical use of patient experience insights, helping to bridge the gap between data generation and real-world application, and enabling PED to more effectively inform decision-making and demonstrate value.

Expanding the Value of In-Trial Interviews

The final session focused on ITIs, an area of rapid growth as the scientific methods and potential for early insights from patients receiving novel treatments are increasingly recognized.

Over recent years, ITIs have evolved from small, exit interview studies to large, global, multi-timepoint research studies generating rich qualitative data.

Their value is increasingly recognized across use cases:

• Supporting endpoint strategy and meaningful change interpretation
• Informing trial design and dose optimization
• Providing context for benefit–risk and tolerability
• Feeding into medical and commercial strategy

However, as studies increase in size and complexity, ensuring that these data are effectively translated into impact remains a key consideration.

Three important perspectives emerged on how ITIs can deliver value:

1. The value of ITIs is context-dependent. Their contribution varies by therapeutic area, study objectives, and stage of development. Across the examples discussed, ITIs were applied in different ways—from identifying previously unrecognized treatment effects in early-phase research to supporting endpoint strategies, interpreting outcomes, and addressing broader evidence gaps. This highlights the importance of designing ITI protocols with clear intent, aligned to the specific questions qualitative research is best placed to address.

2. Despite generating rich insights, ITI data are often underutilized. Traditional reliance on labels or scientific manuscripts alone is insufficient to communicate their value. More effective dissemination requires tailored, engaging, and accessible formats that can reach diverse audiences, including regulators, payers, healthcare professionals, and patients. Examples included the use of visual, multimedia, and AI-enabled approaches to translate qualitative findings into formats that are easier to interpret and apply in practice.

3. Research approaches continue to evolve. While ITIs have their foundations in qualitative methods traditionally used for clinical-outcome assessment (COA) development, their application in clinical trials has become more complex. Studies increasingly capture patient experience longitudinally and in real-world contexts, supported by digitally enabled approaches. These developments reflect a shift towards more flexible and innovative methodologies, better suited to the clinical trial environment and the broader range of questions ITIs are now used to address.

Together, these perspectives highlight that realizing the value of ITIs depends not only on generating high-quality insights, but on how effectively they are translated into decisions that deliver measurable impact and ROI.

Turning Insight into Impact

Across all three sessions, a common theme emerged:

The future of PED is not just about data generation, but about integration, communication, and application.

Key opportunities identified include:

• Embedding PED strategy early in study design
• Developing multi-channel communication approaches tailored to different audiences
• Linking qualitative and quantitative evidence for stronger narratives
• Exploring hybrid value frameworks (operational, perception, and outcome-based metrics)
• Leveraging AI responsibly to enhance (not replace) scientific workflows

Bottom Line

The value of PED is widely recognized, but not yet fully realized.

Unlocking its full potential requires stronger alignment across functions, clearer translation into actionable insights and more sophisticated approaches to demonstrating impact.

By moving beyond data generation to intentional use and communication, PED can play a central role in shaping clinical development, regulatory success, and ultimately, better outcomes for patients.

To learn more about how IQVIA Patient-Centered Solutions can support your PED strategy, please contact Livia Lai for questions related to PED value and ROI, James Turnbull for AI-enabled patient-centered research, or Kim Kelly for in-trial interviews. For more information on PCS, visit https://bit.ly/IQVIA-PCS or contact us.