Beyond Clinical Trials: Listening Is the Work

And the systems that shape healthcare are beginning to respond. The impact is tangible: trials that enroll faster, treatments designed around real life, and development that stays on track. But as Kersten sees it, getting patient voices into drug development was the easier part. The harder question is what happens next.

Clinical trials measure things like treatment efficacy and safety, helping us understand optimal dosing, and potential side effects. Patient engagement data surfaces something different: the practical and emotional realities that determine whether a new therapy is actually workable.

"Patient experience data aren't abstract preferences," Kersten observes. "They're signals about where disease truly impacts people." When trials are designed with patient input, they enroll faster and development stays on track. And in 2024, patient experience data was included across Sanofi's regulatory submissions, reflecting how deeply this approach is now embedded in our work.

Patient engagement has become more embedded in research and clinical development. But Kersten is clear that listening earlier is only part of the picture. "What happens next is what matters – how we act on those insights," she says.

Patient experience data increasingly appears in regulatory submissions and health technology assessment (HTA) dossiers, the evaluations that determine whether health systems will cover and reimburse new treatments. But understanding its influence isn’t always straightforward. Definitions differ between regions, and many HTA frameworks were designed primarily for clinical and economic evidence. As a result, some processes struggle to meaningfully incorporate lived experience, relying on questionnaires that are either too technical or too general to capture what matters most to patients. “The data exists,” Kersten notes, “and the systems are catching up.”

Momentum is building. Belgium is working more closely with patient advocacy organizations and revising processes to better accommodate patient perspectives. Spain has overhauled its system to integrate patient engagement from the start. Turkey is piloting frameworks with patient input built in. Ireland's HTA leadership has publicly acknowledged the need for change and is testing new models.

"We’re seeing real progress," she says. "Systems are recognizing that understanding patient experience isn't optional – it's foundational to making good decisions about access." This is where Kersten believes the next phase must focus: not only generating insight but ensuring health systems are prepared to receive and use it. This call to action includes regulatory and payer authorities: patient experience must be a priority.

Patient engagement is a critical part of our research process to shape better treatments and drive systemic collaboration in healthcare. Eric Low, an independent consultant and patient advocate, shares his perspective on how working together can drive advancements in healthcare.

As conversations about patient engagement evolve, so do discussions about AI. Kersten is direct about its role: "AI doesn't engage patients. People do."

What technology can do is reduce friction and enable the power of people. It can help organize diffuse insights, lower administrative burden, and allow patient organizations to spend more time on meaningful interaction rather than logistics. A patient organization in Brazil uses an AI tool to automatically respond to common questions, freeing staff for deeper conversations. A rare disease group in China analyzed years of emails, calls, and letters to create a map of where patients lived across the country, and this information helped focus both government resources and clinical trial planning. Patient advocacy groups are also exploring AI tools to package the extensive data they collect into formats that regulators can more easily use.

At Sanofi, we’re using AI to help assimilate large volumes of patient data that exist across different departments like market research, clinical development, device design, and public affairs. Right now, these insights live in silos. The goal is to bring them together, so patterns become visible, development gets smarter, and patient voices inform more decisions, faster.

Used well, digital tools make patient voices easier to hear. Used poorly, they risk replacing engagement with assumption. "My biggest concern," Kersten reflects, "is when people think they can infer what patients want without asking them." Technology should make connections smarter and more sustainable, not automate them away.

Patient organizations already do extensive work that sits outside formal healthcare systems: education, caregiver support, school advocacy, and crisis navigation. They answer questions. They help families find resources. They advocate for policy change.

Kersten believes the opportunity now is to be more thoughtful about what we ask of them, and how industry and health systems can support that work rather than add to the burden. Where she sees real potential is in collaboration, particularly when patient groups work together across diseases. Rare disease communities have often led the way in building coalitions that strengthen collective voice and reduce duplication. "Some of the challenges are the same, irrespective of what disease you serve," she notes.

This kind of collaboration should be supported by industry and health systems alike. For Sanofi, our Integrated Patient Engagement is designed to do exactly that, providing structure, tools, and consistency, while keeping engagement itself local and human. "The goal isn’t to centralize everything," Kersten explains. "It’s to empower people on the ground to engage in ways that actually make sense for patients."

We’re also working with patient communities on broader advocacy efforts: providing evidence on sustainable access to innovation, making the case that health is an investment, and helping patient voices shape conversations with governments about healthcare funding. "We're partnering with patient communities to give them evidence they can use," Kersten emphasizes. "Because ultimately, it's patient voice that drives change in health systems."

For Kersten, effective patient engagement isn't measured by the volume of data collected or the number of initiatives launched. It's reflected in quieter outcomes: fewer redesigns, fewer late-stage corrections, fewer misaligned expectations. "When you listen earlier," she says, "you prevent mistakes, instead of fixing them later."

This shift, from correction to prevention, is where she sees the real value. Not as a separate activity. Not as a technological solution. But as a fundamental part of how healthcare works.

Time is the most valuable resource in healthcare – for patients, caregivers, clinicians, advocates, and health systems alike. If patient engagement succeeds, it makes development smarter, access more informed, and systems more responsive to the realities of living with disease.

"Patient engagement isn't about doing more," Kersten concludes. "It's about doing what matters, and building systems that are ready to listen."

To help research keep rising, learn about our clinical trials and how you can volunteer at https://www.sanofistudies.com/global/en/.