Digital Endpoints Are Growing Up. Now We Have to Learn How to Scale Them.

Digital Endpoints Are Growing Up. Now We Have to Learn How to Scale Them.

A few weeks ago, I had the pleasure of being part of a lively panel discussion at the DPHARM conference in Boston on scaling digital endpoints. The panel was chaired by Carrie Northcott (Pfizer), with Abhishek Pratap (Boehringer-Ingelheim), Marie Rosenfeld (Entrada Therapeutics), Srinivasan Vaireva (J&J) as my fellow panelists.

Reflecting on the discussion, I was struck by how much the conversation has evolved. A few years ago, the central question was whether digital measures could reliably capture meaningful, validated, fit-for-purpose data outside the clinic and earn the confidence of regulators and sponsors. Those questions still matter, but the challenge is shifting from proving the value of digital measures to making them routine in clinical development. The question now is how do we scale?

From Individual Studies to Portfolio Thinking

One of the biggest barriers to scale is the tendency to evaluate digital measures within the context of a single asset or a single clinical trial. That approach is often necessary to get started. Most innovations begin with a focused scientific question, and organizations understandably want to demonstrate value in a specific program before expanding further. The risk, however, is that we can end up treating every implementation as a completely new exercise.

If we want digital measurement to become more broadly adopted, we need to think more deliberately at the portfolio level. We should be asking where a measure, insight, or operational approach could create value across multiple assets, indications, or development programs. When organizations identify opportunities for reuse, the economics change. Validation efforts become more valuable, operational teams build expertise more quickly, and lessons learned from one program can be applied to the next. Over time, this creates the consistency and efficiency that are necessary for scale.

The future of digital measurement will not be built solely by running more pilots. It will be built by finding ways to leverage what we have already learned.

The Opportunity Is Bigger Than Replacing Existing Endpoints

When people hear "digital endpoint," there is often an assumption that the goal is simply to digitize an existing assessment. While there may certainly be situations where that makes sense, I think the more interesting opportunity lies elsewhere.

Digital measures allow us to observe aspects of patients' lives and experiences that have historically been difficult, or sometimes impossible, to measure. Traditional clinical assessments are invaluable, but they often provide snapshots taken during clinic visits. Patients, of course, do not experience their disease only during those visits. Their daily lives unfold between appointments, in their homes, workplaces, schools, and communities.

Digital measures offer the potential to bridge that gap. Whether it is understanding activity patterns, sleep, stress responses, cognition, or other aspects of daily functioning, these technologies give us the opportunity to generate a more complete picture of how patients are actually doing in the real world. They may also help us understand therapeutic effects that would otherwise be difficult to observe using conventional approaches. What excites me most is not necessarily the technology itself, but the possibility of generating a more complete understanding of treatment benefit and patient experience. In many ways, the field is moving from measuring what is easy to measure toward measuring what really matters.

Validation Is Essential. Execution Is What Creates Scale.

As much as we focus on validation, one of the realities highlighted during the panel is that operationalization can be just as challenging. A scientifically sound measure is only one piece of the puzzle. Success also depends on whether patients can use the technology, whether sites can support it, whether data can move reliably through multiple systems, and whether teams have visibility into quality and compliance throughout a study.

These are rarely the topics that generate headlines, but they are often the factors that determine whether a digital measure succeeds or fails in practice. The good news is that our industry has accumulated a vast amount of experience over the past decade. We have learned valuable lessons about device deployment, participant support, data monitoring, quality management, and technology integration. Those lessons are helping organizations develop far more mature and scalable implementation models than were available just a few years ago. The more organizations implement digital measures, the better the entire ecosystem becomes.

Looking Ahead

My overall takeaway from the discussion was one of optimism. The field is continuing to mature. We are seeing growing experience across sponsors, technology developers, academic institutions, regulators, and patient communities. We are building a better understanding of both the opportunities and the challenges associated with digital measurement.

There is still important work ahead and we still need the big win of a labeling claim being secured based off a digital endpoint. We need more evidence, more examples of successful implementation, and continued confidence-building across the ecosystem, but the conversation is evolving. We are no longer debating whether digital measures belong in clinical development: we are discussing how to deploy them effectively, efficiently, and at scale.

Postscript: Two Topics We Didn't Have Time to Discuss

As often happens with conference panels, there were several important topics we simply didn't have time to explore in depth:

1. Cross-functional collaboration
2. Pre-competitive, cross-industry collaboration

Digital measures are often discussed within digital health teams or within dedicated digital conference tracks. While those communities play a critical role in advancing the field, I sometimes worry that we spend too much time talking to ourselves, that we are often “preaching to the choir”.

The reality is that the long-term success of digital measures depends on much more than technical performance or validation. Decisions about development strategy, trial design, operational feasibility, regulatory acceptance, evidence generation, reimbursement, and commercialization involve a much broader set of stakeholders. Clinical development, clinical operations, biostatistics, regulatory, market access, medical affairs, commercial teams, and technology partners all bring important perspectives.

In my experience, one of the biggest barriers to scale is not a lack of interest in digital measures, but rather that discussions about digital measurement often happen separately from the broader conversations where development and business decisions are being made.

If we want digital measures to become a routine part of clinical development, we need to move beyond treating them as a specialist topic and engage the full cross-functional ecosystem much earlier in the process.

Many of the challenges we face, including standards development, validation approaches, evidence generation, and implementation best practices, are not unique to any single organization. Progress in these areas benefits everyone. Those of us working on digital measures often say that pharmaceutical companies “compete on drugs, not on the measures”, but pre-competitive collaboration efforts have historically been quite limited. In recent months, I have seen increasing interest in pre-competitive efforts to harmonize measurement concepts and obtain regulatory input. I find this growth in collaborative activities to be very encouraging – not only is there strength in numbers in terms of establishing standards, but sharing the costs and effort of endpoint advancement across organizations improves scalability.

For the industry to adopt digital endpoints at scale, collaboration may ultimately prove to be just as important as innovation. After all, scaling is not something any one company will achieve alone; it is something we will achieve as an ecosystem.