Every year, SCOPE brings together the people running clinical trials—sponsors, CROs, site leaders, technology vendors—to take stock of where the industry stands. This year, the honest answer was "capable, but stuck.

Not stuck for lack of ideas. The sessions were full of smart thinking on AI, digital endpoints, site partnerships, and patient engagement. The gap isn’t conceptual anymore. It's operational. The industry knows what good looks like. Getting there consistently is another matter.

A few themes cut across nearly every track we attended.

Patients Are Still Absorbing Costs the System Should Own

The opening plenary set a tone that carried through the rest of the conference. Two CAR-T trial participants described what participation actually required: months of searching for eligible trials, travel across state lines, significant out-of-pocket expenses, and consent processes that assumed far more bandwidth than most people have when they’re frightened and unwell. Hope got them through the door. The logistics nearly didn’t.

This wasn’t presented as an indictment of any single sponsor or site. The point was structural: the system has consistently offloaded administrative, financial, and emotional burden onto the people least equipped to carry it. Merck’s CMO put it plainly—much of the data collected in trials is rarely used, yet it adds visits, complexity, and cost for patients without a proportional return. Simplification isn’t a nice-to-have. It’s overdue.

Enrollment Is a Friction Problem, Not an Awareness Problem

A 37-page informed consent document doesn’t fail because patients aren’t engaged. It fails because it’s a 37-page document.

The recruitment track pushed back on a persistent industry assumption. The dominant framework has been that patients don’t enroll because they don’t know trials exist. The data tells a different story: the majority of trial participants already come from within existing site populations. The drop-off isn’t at awareness—it's screening, consent, and the first few weeks of participation.

Fifteen-day screening windows lose 50–65% of diverse populations not because those patients aren’t motivated, but because the process doesn’t fit their lives. Fixing enrollment means fixing the experience, not expanding the funnel.

Sites Are at Capacity, and Fragmented Sponsor Engagement Is Making It Worse

The site operations track surfaced something sponsors don’t always see clearly from the inside: sites experience a sponsor as one organization, even when R&D, medical affairs, and clinical operations are operating independently. The result is duplicative outreach, inconsistent messaging, and a growing administrative burden that erodes site relationships over time.

Speakers from Amgen and Boehringer Ingelheim were candid about this — it’s a structural failure, not intentional neglect. The Takeda–Mayo Clinic partnership offered a more useful model: a relationship built above the study level, with shared timelines, honest escalation, and enough trust to compress site activation from a 40-week norm toward a 16-week target. That outcome wasn’t driven by technology. It was driven by alignment.

Digital Measures Are Past the Proof-of-Concept Stage

The conversation in the digital measures track has matured. The question is no longer whether wearables and continuous monitoring can capture meaningful clinical data—they can, and in several indications they outperform traditional clinic-based assessments on sensitivity. The question now is how to make that evidence count with regulators and how to operationalize it at scale.

The FDA is already accepting digitally derived endpoints in some submissions. The infrastructure for adoption exists. The work now is execution: selecting the right endpoints forthe right indications, validating them appropriately, and building them into study designs from the start rather than retrofitting them later.

AI Is Moving From Pilots to Production—and That Requires More Technology Decisions

The AI sessions were notably less focused on capability demonstrations than in previous years. The consensus among panelists from AstraZeneca, EMD Serono, and AWS was that the industry has figured out how to run pilots. It hasn’t figured out how to scale production systems.

Meaningful acceleration—the kind that actually compresses development timelines rather than improving productivity within existing ones—requires redesigning decision points before execution begins. It requires AI embedded in existing workflows, not added alongside them. And it requires organizational change that most companies are still working through. The technology is ready for more than the industry is currently asking of it.

The Gap Between Knowing and Doing

The throughline across all ofit: the next phase of progress in clinical research depends less on new invention than on closing the gap between what the industry knows and what itconsistently does. The tools exist. The evidence exists. The case for simpler, more patient-centered, better-coordinated trials has been made repeatedly. SCOPE 2026 suggested the industry is getting more honest about what’s actually in the way.

These are the challenges ObvioHealth works on every day—and why we think unified, participant-centered trial technology matters more now than ever.

Tim Giacomini is VP of Business Development, and Richard Watkins is Chief Revenue Officer at ObvioHealth.

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