By Erik Yorke 

September 30, 2025 | The clinical research industry is awash in new data streams. With the rise of wearables, sensors, and smartphone-based assessments, objective digital measures are increasingly complementing traditional patient-reported outcomes. But should these endpoints be combined, or is it better to keep them separate? A recent SCOPE 365 ClinEco Connect session brought together experts and industry participants to wrestle with this question. Moderated by Kai Langel, CEO of DEEP Measures, and Farrell Healion, Founder of OptiTrial, the conversation explored opportunities, challenges, and what it will take to move forward responsibly. 

It's a Golden Age of Data, But Proceed with Caution 

Attendees agreed: we are entering an era where data capture is richer and more continuous than ever before. Patients can share context through apps in real time, while wearables monitor gait, sleep, or heart rate variability around the clock. As Healion noted at the outset, this “golden age of data” creates unprecedented opportunities to paint a full picture of patient experience.  

Yet, as Langel noted, the industry should move forward with caution. Drawing on his two decades of work in eCOA and digital health, he emphasized that while merging objective and subjective data may sound powerful, it often adds complexity instead of clarity  

“It’s not as simple as you might think,” he explained. “For some contexts—such as natural history studies or quality-of-life research—composite measures might provide added insight. But in registrational trials, where precision is paramount, blending endpoints can dilute the signal.” 

Innovation at the Intersection 

Participants shared examples where integration shows promise. One case involved micro-questionnaires delivered when a patient unlocks their phone—capturing subjective input in the moment of an objective observation. Another explored geo-fencing to detect emergency room visits in real time, potentially triggering immediate follow-up questions. 

Still, the group recognized that operational hurdles remain steep. Triggers between systems are technically difficult. Validation requirements are stringent. And regulatory acceptance depends on showing that composite endpoints are more meaningful, not just more complicated. 

As Healion summarized, “You can create the perfect plan, but once it reaches patients, you often realize what’s missing.” 

The Patient Experience Must Come First 

Several attendees stressed that any innovation must ultimately serve patients. Examples included gamification techniques that boost diary compliance in younger populations, and adherence strategies tailored to elderly patients who often outperform expectations when properly trained. 

Bring-your-own-device approaches surfaced as another way to reduce patient burden. “Nobody wants to carry two phones—or two watches—just to be in a trial,” Healion said. Aligning study technology with the devices patients already use may prove essential to long-term success. 

Toward Smarter Integration 

The session concluded with optimism tempered by realism. New use cases, such as real-time feedback loops between wearables and ePRO apps, are on the horizon. Steve Simpson, Head of Sales and Business Development at Replior, described work connecting UV exposure sensors with alerts to protect dermatology patients from excess sun, illustrating how objective and subjective data can inform behavior in real time. 

Yet the consensus was clear: combining eCOA, ePRO, and digital measures is not a universal solution. It must be pursued thoughtfully, with statistical rigor, regulatory dialogue, and above all, patient usability in mind. 

“Researchers need to ask two questions before merging endpoints: ‘Will this be more meaningful to patients?’ and ‘Will it make the research signal clearer?’ If the answer is no, separation may still be the wiser path,” Langel said. 

This discussion was part of the SCOPE 365 ClinEco Connect series. To explore upcoming sessions or review summaries from past events, visit www.clineco.io/meetups.