Speakers
· Sarah Small, Director, Health Experience Development, Otsuka
· Seth Ginsberg, CoFounder and President, Global Healthy Living Foundation
· Jigna Heble, Senior Global Medical Lead, Dupixent COPD, Sanofi
· Andrés Escallón, Vice President, eCOA Solutions Strategy, Suvoda
· Stephen Framil, Corporate Global Head of Accessibility, Merck
Key Takeaways
· Embed accessibility standards in vendor contracts before trial deployment
· Protocol simulations with patients expose technology usability gaps early
· Cross-industry patient trust enabled Dupixent's first-in-class COPD breakthrough
· Over 50% of participants enroll altruistically yet receive minimal feedback
· Consumer technology expectations now define baseline trial system requirements
When Trust Becomes the Trial Endpoint
The final panel at Clinical Innovation 2025 opened with a pointed observation: everyone remaining in the room had chosen to stay for a conversation about trust rather than head to cocktails. That choice mattered. As Seth Ginsberg framed it, the session would explore trust as "proper currency" and "the essence of clinical research."
The moderator's framing proved prescient. Within minutes, the discussion moved from abstract principles to lived realities. Ginsberg identified the core problem based on patient feedback: "Misunderstanding or feeling like it was never explained to them in any way they could comprehend seems to be what we hear over and over from patients. They can't trust what they don't understand or know. "
Stephen Framil's self-introduction set the tone for what followed - not credentials, but connection.
Accessibility as Infrastructure not Afterthought
Stephen Framil brought an unusual dual perspective to the accessibility conversation both as Merck's Corporate Global Head of Accessibility and as a cancer patient. His opening self-description went beyond typical panel introductions:
"It was two years ago about this time I was finishing up my regimen of chemo for colorectal cancer, Stage 3B, and no evidence of disease for the last 18 months...the neuropathy in my fingers and more so in my toes, but the cold sensitivity...just the tremors in your hands when you're trying to type on your keyboard and you wish you had, like, voice prompts. "
That lived experience shapes Merck's strategic approach. Rather than relying on individual champions or post-development retrofits, Framil described embedding requirements at the source: "Whatever the digital interface is, anytime you have a digital interface with human beings, then you need to have accessibility. The way we're approaching accessibility broadly at Merck is really accessibility by design...You have to have it into your processes and your systems so that it gets accounted for."
The tactical implementation surprised even experienced trial professionals in the room. Framil's recommendation for immediate action: "With your procurement organization and all the suppliers you're bringing in, you can get accessibility language into the MSAs and contracts so that your suppliers, anyone who's providing a digital product or service has to meet the Web Content Accessibility Guidelines version 2.2 AA."
This procurement-level intervention creates systematic compliance rather than case-bycase negotiation. The approach addresses a fundamental disconnect between sponsor expectations and participant experience. Andrés Escallón reinforced the business case beyond compliance:
"When participants feel pigeonholed because they don't have those features and yet apps that they use every single day have that available, how does that make the solutions that pharma is trying to implement, how does it build that trust? It doesn't. "
The message: accessibility features aren't accommodations- they're baseline expectations shaped by consumer technology. Participants who navigate sophisticated accessibility features in banking apps, social platforms, and health tracking tools expect equivalent functionality in trial systems. When clinical technology falls short of consumer standards, trust erodes before the first dose.
Protocol Simulations Expose Shiny Toy Problem
Sarah Small has spent a decade in digital health and quantitative medicine, but one early experience continues to drive her approach. As a 23-year-old clinical research coordinator enrolling CNS patients, she heard a request that changed everything:
"I had one patient who said, I just want to take a drug that allows me to be with my grandchildren longer and remember their names and be able to show up as myself. And it changed the way that I view what I do every day because there's someone out there waiting for a drug to come to market. "
That patient-first mindset now informs Otsuka's technology deployment strategy through protocol simulations- testing with actual patients before trial launch. The results consistently reveal industry blind spots. Small described the pattern: "I think in the industry, sometimes we think, oh, this new shiny toy, this new technology, it's so cool. It's going to be so easy to use. And then during the protocol simulation, when you actually put it in someone's hands...they're like, why? Like, why are you making me do this thing?"
Market research facilities host these sessions in collaboration with patient advocacy groups, bringing together site coordinators, investigators, and potential participants to walk through proposed protocols. The exercise tests both technology usability and visit logistics. What looks elegant in sponsor presentations often reveals friction points when actual patients attempt navigation with tremor affected hands or cognitive impairment.
The approach delivers direct ROI by identifying design flaws before expensive trial launch. Small shared a progressive supranuclear palsy example where technology provided uncomfortable clarity: "As part of this Phase 2 pivotal trial, we actually decided to change the algorithm in the gyroscope of a fall detection device...And as a result of adding that technology into the clinical trial, unfortunately, what we saw was that the drug wasn't working” .
The modified fall detection captured all falls, not just catastrophic ones requiring emergency response. The data showed no reduction in fall frequency, prompting trial termination. This protected patients from ineffective treatment while redirecting investment toward more promising candidates. Protocol simulations also surface opportunities for flexibility- telehealth options, adjustable visit windows- that expand access for working parents, caregivers, and rare disease patients facing multi-hour travel to sites.
Cross-Industry Patient Trust Fuels Breakthrough
Jigna Heble's connection to clinical trials became intensely personal when her father faced stage three colorectal cancer. His experience illuminated what participation truly means: "When he was diagnosed with colorectal cancer, actually at stage three, almost stage four, his only option was to enroll in a clinical trial...when he was able to survive even for three or four months and take a trip without being on any medication and being attached to something, it was very impactful. "
That understanding now informs her work on Dupixent's COPD indication at Sanofi, where patient trust across multiple failed industry trials created breakthrough opportunity.
Heble explained: "Dupixent got the COPD indication and we went straight into Phase 3 thanks to the patients who participated in previous trials with other large pharma. And unfortunately those studies did not get the regulatory approval...our first study was based on the learnings from the two other compounds that had not made it. "
The development pathway demonstrates how patient willingness to enroll despite predecessor failures creates scientific infrastructure for eventual success. Two earlier biologics failed to achieve regulatory approval in COPD, yet patients continued participating in subsequent trials. Sanofi leveraged those learnings through enrichment strategies, identifying biomarker profiles most likely to respond. The result: first-in-class biologic status and better-in-class positioning when the second COPD biologic later reached market.
This cross-industry patient trust- willingness to enroll despite repeated disappointments represents critical infrastructure for innovation in difficult therapeutic areas. Without sustained participation across failed attempts, breakthrough discoveries remain impossible. Heble advocates capturing this patient contribution in more meaningful ways: "Capturing activities of daily living, how much interaction they have with their grandchildren or how many meters they're able to walk or maybe in a more lay format. I think things like that are very meaningful. "
These patient-reported outcomes in plain language complement validated instruments, providing context that resonates with regulatory reviewers and prescribers. A patient's ability to walk additional meters matters less than what those meters enable attending a grandchild's soccer game, walking through a grocery store independently, maintaining employment.
Closing the Altruism Feedback Loop
The panel's most provocative insight came from recent participant research. Escallón cited survey data revealing that "over half of participants that chose to do a trial was due to altruistic reasons. And if that's the case, that means that they're very, very interested in what is happening not just to them, but what is happening to the work that they're participating in...we owe it to them to come back to them and tell them how it's going. "
This transparency gap represents both ethical failure and missed opportunity. Participants enrolling to help others deserve meaningful updates on trial progress and scientific impact, yet regulatory concerns and system limitations create barriers. Technology providers and sponsors face challenges providing feedback without compromising blinding or creating unintended interpretation of interim results. Recent engagements show sponsors asking whether patients can participate in user acceptance testing- not validation studies, but actual system testing before go-live. This represents meaningful inclusion in trial infrastructure development.
Small's closing recommendation cut through complexity: "Ask patients first...If we're developing drugs without asking patients what they actually care about, then we're probably in the wrong room. It's meaningful to not just listen to them, but then take some level of action. "
The distinction matters. Patient advisory boards that generate recommendations filed away represent performative inclusion. Patient feedback that modifies visit schedules, informs technology selection, or shapes endpoint measurement demonstrates genuine partnership. Even small actions signal respect— travel stipends, flexible visit windows, incorporating patient-generated health data they already collect. Ginsberg offered a final frame from caregiver feedback that captures the relationship imperative: "I remember a while back hearing from a caregiver. She told me, I'll never forget, she said, we trusted the trial long before we trusted the treatment...I don't know what I'm taking, but I know the people who are taking me through it, and I trust them because I understand what they're doing."
The observation reveals a fundamental insight about clinical research relationships. Trust doesn't require certainty about treatment efficacy - that's what trials determine.
Trust requires certainty about human relationships, transparent communication, and respect for participant agency. When site teams take time to explain procedures, when technology adapts to patient preferences rather than forcing adaptation, when accessibility features match consumer expectations, trust compounds. That accumulated trust becomes the foundation enabling breakthrough discoveries across failed attempts and difficult therapeutic areas where sustained patient participation determines whether innovation succeeds or stalls.
To get you the highlights of Pharma Clinical Innovation USA 2025 faster, we are using generative AI technology to summarise the transcripts of the sessions. The conference organiser is checking the summary for accuracy. If you have any feedback about the summary and the post-event report, please contact lucy.fisher@thomsonreuters.com
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