What If Patients Were the Most Powerful Source of Real-World Evidence?

Real-world evidence (RWE) has become indispensable to life sciences research — informing regulatory decisions, accelerating access and strengthening health outcomes. Yet, much of this evidence still relies on structured datasets that miss the emotional nuance, lived context and day-to-day complexities of health journeys.

In this Xtalks Spotlight interview, Dr. Joseph L. Smith, Senior Director of Scientific Solutions & Strategy at Inspire, shared how patient communities are redefining what counts as evidence.

By harnessing candid, anonymized conversations, these communities offer a window into what patients and caregivers actually experience — and how their voices can complement, challenge and even outpace conventional data sources.

From early detection of side effects to surfacing barriers in access and trial design, patient-driven insights are transforming the future of evidence generation.

Rethinking Real-World Data

RWE begins with real-world data (RWD), but as Dr. Smith explained, there’s often a disconnect between the data collected and the stories behind it.

“Real-world data comes from things that happen to patients and caregivers in the normal course of care,” he said.

That includes electronic medical records (EMRs), claims data, wearable devices, apps, patient-reported outcomes (PROs), surveys and more.

But understanding why certain patterns emerge — why patients discontinue therapy, report poor adherence or describe unexpected side effects — often requires going beyond structured inputs.

“In order to really get into that why, we have to use some of these deeper methods like patient voice,” Dr. Smith noted. “It fills some of the critical gaps that are occurring within the clinical trials that we’re not able to answer either ethically or practically.”

By combining structured and unstructured data, researchers can build a more complete picture of the patient experience — one that better reflects real-world challenges and opportunities for improvement.

From Raw Emotion to Rich Insight

Inspire’s anonymized patient communities offer a space where individuals can share openly — not just about symptoms or treatment outcomes, but about fear, frustration and resilience. According to Dr. Smith, this openness creates a deeper kind of dataset, one that’s both emotionally honest and highly informative.

“When people feel safe, seen and heard, they share with a level of honesty that traditional studies often miss.”

— Joseph Smith

These unfiltered conversations reflect the reality of living with a condition — what it feels like day to day, how it impacts relationships, work and self-perception, and what patients are actually thinking when they make decisions about their health.

This is insight that rarely surfaces in surveys or structured interviews, where clinical language and formal settings may inhibit expression.

Dr. Smith recalled a study on anhedonia, a symptom of depression marked by a loss of pleasure. While clinical terminology rarely showed up in community discussions, phrases like “not interested,” “feeling tired” or “don’t enjoy things anymore” appeared frequently.

“We were able to piece together this picture of what anhedonia means to patients in their real world using their own voice,” said Dr. Smith. “And that’s powerful.”

This linguistic nuance not only enhances scientific understanding, but also informs more empathetic communication and care delivery. By listening to how patients describe their experiences in their own words, researchers and healthcare professionals can develop more relatable messaging, more patient-friendly tools and even more precise definitions for clinical endpoints.

It’s a reminder that the language of health isn’t always found in textbooks — it’s being spoken every day in the spaces where people feel free to be themselves.

When Communities See It First

One of the most compelling advantages of patient-driven communities is their ability to detect emerging trends before they appear in the clinical literature — often months in advance.

These communities operate in real time, capturing the nuances of patient experience as they unfold, offering a window into unmet needs and unreported side effects that might otherwise go unnoticed until much later.

Dr. Smith shared multiple examples where Inspire’s communities surfaced critical developments well ahead of official recognition — from barriers in medication access to early symptom patterns in newly emerging conditions.

“As we know, GLP-1s have become exceedingly popular, but there’s also a lot of challenges with getting your insurance to cover it. And within these communities, we’ve seen that patients have started to detail how exactly they’re going about getting these medications without going through their insurance company or finding alternative services,” shared Dr. Smith.

“In a second example, we found patients with COVID had identified some of the long COVID symptoms over six months before the formal recognition. And so we were able to use some of that to piece together what a long COVID syndrome might look like,” he explained.

In another case, Inspire collaborated with a pharmaceutical sponsor to monitor the safety profile of a product in development. What they uncovered was striking: adverse events were being discussed in patient conversations well before they were formally reported to the FDA.

“I think all of this is really important because a lot of the publications you see are lagging by 12 to 18 months after the research is completed. So, there’s really a long delay between when the actual evidence is generated to the time that it’s disseminated,” Dr. Smith emphasized.

This lag has real implications. The earlier a safety concern or behavioral trend is detected, the faster sponsors, regulators and clinicians can respond. Patient communities, when approached responsibly, become a form of real-time pharmacovigilance — supplementing traditional data systems with firsthand observations that are current, candid and context-rich.

By listening to where patients are already speaking, sponsors can adapt faster, communicate more effectively and ultimately deliver safer, more responsive therapies.

Building Trust Through Responsible Data Use

Collecting community-driven insights comes with clear ethical responsibilities — not only to protect personal information but also to honor the voices behind the data.

At Inspire, this responsibility is foundational, guided by a three-pillar policy: privacy by design, value exchange and transparency.

“Privacy by design means we’re always consenting patients to allow us to use their data — and all of this is governed by HIPAA, GDPR and other regulations,” Dr. Smith said. This proactive approach ensures that privacy isn’t an afterthought or a checkbox, but an embedded principle that shapes every stage of research, from study design to dissemination.

“We want to make sure that everything we’re doing is communicated back to the patients in both the upfront consenting and then later as we’re using the data, so that patients are always partners of ours and not just participants.”

— Joseph Smith

Equally important is recognizing the value that patients bring to research — and ensuring that value flows both ways.

Inspire often creates tailored infographics, summaries or visual data stories to share the results of studies directly with the communities that contributed their experiences.

These feedback loops turn participation into partnership and reinforce a sense of shared purpose.

This commitment to transparency also means being open and intentional about how data is used, what questions it helps answer and what impact it has on care or innovation.

At Inspire, clear communication is vital — not just at the point of consent, but throughout the data lifecycle — so patients always know where their contributions are going and how they’re making a difference.

The Future of Communities in Research and Care

Looking ahead, Dr. Smith envisions two major shifts. First, patients and caregivers will increasingly be treated as strategic advisors in trial design, informed consent development and beyond.

Dr. Smith shared an example of when a study sponsor sought feedback on their clinical trial design and informed consent form. “They wanted to make sure the patients understood the protocol and the informed consent, and then they wanted to make it much easier for people to participate and see the outcomes that they were hoping to see in the research,” he shared.

Second, Dr. Smith sees patient communities evolving into the early infrastructure for future research registries. Unlike traditional registries, which can be rigid and resource-intensive to launch, patient communities already have the most important foundation in place: trust, engagement and shared purpose.

“These communities are formed for connection, support and education — but that doesn’t mean that’s all they can be,” he said.

With sustained participation, these networks can evolve, where patients contribute EMRs, PROs, survey responses and more through longer-term engagements. The result is a rich, disease-specific dataset that offers a granular, real-time view of how patients live with — and manage — their condition.

Patient communities are no longer just passive support networks. As Inspire’s work shows, they are important sources of insight — capable of surfacing unmet needs, influencing protocol design and providing a real-time lens into the human side of health data.

By treating patients as partners and their voices as evidence, the life sciences industry can unlock a deeper, more inclusive model for research, care and innovation.

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.