Embedding the Patient’s Voice in Drug Development

Embedding Patient Input from Discovery to Delivery

Many life science organizations recognize the value of patient input, but few integrate it meaningfully across every stage of development. According to Dr. Williams, this integration must begin at the earliest phases and be sustained.

“The most impactful thing that any company can do is to continuously engage the patient,” she said. One key strategy is the creation of patient advisory councils — diverse groups of individuals who share insights into their health journeys, challenges, expectations and unmet needs. These stories help contextualize disease burden in ways that data alone cannot, providing directional input on what interventions matter most.

Surveys, focus groups and real-world experience collection complement these councils, offering both qualitative and quantitative insight into the patient journey.

“When you know what their values and expectations are, you can decide where to intervene — what would be most beneficial in terms of the innovation you’re working on,” Dr. Williams explained.

But capturing patient feedback isn’t enough. True impact comes from turning insight into action. At Ardelyx, patient-centricity is institutionalized through governance. It’s built into performance goals, measured with defined metrics and rewarded when it drives outcomes. “You highlight the value and the success of these processes,” she said, “and by doing so, you amplify the voice of the patient.”

Crucially, this voice is represented at the highest levels of the organization. Dr. Williams reports directly to the CEO, a structure that ensures patient insights shape — not follow — strategic decisions. “You have the right people at the table,” she said. “And decisions are made through the lens of the patient.”

Digital Support Programs: Meeting Patients Where They Are

In addition to human-centred design, Ardelyx is expanding its use of digital-forward patient support tools to improve access, equity and experience. From streamlining enrollment to improving disease literacy, these platforms reduce friction and provide real-time engagement opportunities tailored to individual needs.

“Our patient assistance program uses a digital platform that simplifies enrollment,” Dr. Williams shared. “It ultimately improves access to our medications — and it does so in a fair and equitable manner.”

But support extends far beyond access logistics. Patient portals offer medication reminders, trial participation updates, educational videos and interactive infographics. These features empower patients to understand their disease better, navigate care decisions and remain adherent to complex treatment regimens.

As patient populations become more digitally diverse, inclusive design is paramount.

“Mobile-first tools, low-bandwidth options — those are crucial for usability, especially for patients who may not have broadband or smartphones,” she explained. These tools ensure that geography or socioeconomic status doesn’t preclude engagement, particularly for individuals in rural communities or medically underserved areas.

In addition, Ardelyx is investing in personalized communications, language and health literacy optimization and omnichannel touchpoints that connect with patients on their terms.

“We use a number of these tools today,” Dr. Williams said, “but I envision increased utilization going forward because I think it only helps the patients we’re trying to serve.”

Whether it’s a chatbot that answers medication questions in real time or a culturally relevant infographic explaining trial participation, these resources extend the reach and relevance of engagement strategies.

Community-based collaboration remains a critical complement to digital solutions. Partnerships with nonprofit organizations, local clinics and advocacy groups are essential for building trust and tailoring outreach.

Designing Trials That Reflect the Real World

One of the industry’s most persistent challenges is ensuring that clinical trial populations reflect the patients who will ultimately use the therapy. Underrepresentation of key groups can lead to therapies that are less effective — or even unsafe — for segments of the population.

Dr. Williams outlined a clear, structured approach. “You have to understand the epidemiology of the disease,” she said. “What are the pertinent demographics — age, gender, race, ethnicity? Where are those patients located?”

“Trust is everything. And you build trust through open, transparent communication that’s based in empathy.”

— Laura A. Williams

Once identified, the next step is outreach. Ardelyx collaborates with patient advocacy organizations, community leaders and healthcare providers who already serve underrepresented populations. These partnerships help extend trial awareness and build trust.

Equally important is ensuring that trial staff and site personnel reflect the diversity of the patients they serve. Cultural competency and representation help reduce barriers to participation and foster more meaningful engagement.

The results speak for themselves. In Ardelyx’s chronic kidney disease (CKD) clinical trials, African Americans made up 45% of participants, and Hispanics 28% — a representation that closely aligns with the disease’s disproportionate impact on those groups. “That was intentional,” Dr. Williams said, “because those groups bear a disproportionate burden of the disease.”

Building Trust with Underrepresented Communities

For many patients, particularly in marginalized or historically excluded communities, clinical trial participation is fraught with skepticism, often for good reason. Addressing that legacy requires more than recruitment incentives; it requires a genuine, long-term partnership.

“We have to lead with empathy,” Dr. Williams emphasized. “We must listen to understand, not just to respond. You can’t camouflage sincerity — people know when you’re not being genuine.”

Building that trust starts with presence. While financial investment is valuable, visibility and ongoing support often matter more. Ardelyx partners with faith-based leaders, cultural organizations, local elected officials and community health workers — individuals already trusted in the communities they serve.

These efforts are reinforced by collaborations with national organizations like the National Kidney Foundation and the American Kidney Fund, which help amplify outreach and connect patients with trials relevant to them.

Engaging academic institutions and regional health systems also plays a role, particularly in areas where infrastructure may be limited. Through these partnerships, Ardelyx is able to bring trials to the patient — not the other way around.

As Dr. Williams noted, “Empathy builds trust, and trust enables access. That’s how we create better outcomes — not just for individuals, but for the healthcare system as a whole. The patients are waiting…”