The clinical trial industry has never had more technology at its fingertips. AI platforms, decentralized trial tools, electronic informed consent systems, and digital data collection methods are no longer futuristic concepts — they exist today, are regulatory-ready, and have been proven in practice. And yet, the industry continues to lag behind in one critical area: adoption.
At SCOPE Summit, Craig Lipset, co-founder of the Decentralized Trials & Research Alliance (DTRA), delivered a candid, unfiltered assessment of where clinical innovation is genuinely moving — and where it keeps getting stuck. His message was clear: the tools are here, regulators are engaging, and the real obstacle is the industry’s own resistance to change.
FDA Engagement With Digital Trial Tools Is Growing
One of the more encouraging takeaways from Lipset’s conversation was the FDA’s increasing willingness to engage with digital trial technology. A recent DTRA workshop brought the agency together with sponsors and technology developers to focus specifically on inspection readiness and digital tools. Rather than remaining a source of uncertainty, the FDA appears determined to demystify how new technologies will be evaluated during inspections.
What FDA Participation Signals To The Industry
Lipset described the agency’s involvement as “very revealing,” noting that regulators want to ensure sponsors and sites don’t fear how inspectors will respond to digital innovations. With the number of active inspectors currently reduced and discussions around aggressive rehiring underway, there is a real window of opportunity for inspection standards to evolve alongside technology.
More provocatively, Lipset raised a question that the industry should be asking itself: What happens when inspectors stop questioning why you’re using digital tools — and start questioning why you’re still using paper? That shift in framing could be the catalyst the industry needs.
The Paper Vs. Digital Debate Must Come To An End
Electronic informed consent is one of the clearest examples of where digital tools simply outperform paper. Time stamps, version tracking, and auditability are built-in features that paper cannot replicate. As high-profile legal cases involving falsified paper source documents continue to emerge, the argument for maintaining paper-based processes becomes increasingly difficult to defend.
Why Paper Persists Despite Better Alternatives
Despite the clear advantages of going digital, paper informed consent remains commonplace across clinical trial sites. This persistence isn’t about technology being unavailable — it’s about organizational inertia, risk aversion, and a lack of structured processes for implementing change at scale.
AI In Clinical Trials: Is The Industry Really Ready?
Walking the exhibit floor at SCOPE, Lipset observed what has become an industry-wide pattern: AI everywhere. Every booth, every pitch, every panel seemed to feature artificial intelligence as its centerpiece. But his follow-up question cuts to the heart of the problem — is the industry actually ready to operationalize any of it?
The Gap Between Innovation Showcasing And Real Implementation
Lipset captured the disconnect perfectly with a cartoon he referenced: agentic AI robots standing around a fax machine, sending paper informed consent forms. It’s an absurd image, but it reflects a genuine tension in the industry. Pharma organizations are extraordinarily skilled at managing therapeutic development pipelines — but when it comes to managing process innovation, the funnel is, in his words, “constipated.”
The last major technology to achieve global enterprise-scale adoption in clinical trials? Electronic Data Capture (EDC) — and that was decades ago. The industry must stop chasing the next shiny tool and focus on scaling what is already proven and available.
Decentralized Clinical Trials: Normalized Or Still Toxic?
DTRA’s membership has grown steadily since its founding, with pharma sponsors increasingly joining the alliance. But the picture Lipset paints of decentralized clinical trials (DCTs) is one of two very different realities depending on who you ask.
A Divided Industry Perception Of DCTs
Some groups within the industry consider decentralized trials fully normalized — a standard operating approach. Others describe decentralization as “toxic,” something they struggle to sell internally or to external stakeholders. This divide reflects a broader challenge: even when a solution is proven, getting organizational buy-in at scale remains deeply difficult.
Lipset also noted a persistent disconnect between what vendors and suppliers think sponsors want and what sponsors actually need. Bridging that gap requires more honest dialogue, better listening, and a focus on practical implementation over theoretical capability.
The Buffalo Initiative: Where Urgency Drives Adoption
Perhaps the most inspiring segment of Lipset’s conversation was his discussion of the Buffalo Initiative, a nonprofit effort focused on advancing therapies for ultra-rare diseases using platform trial approaches and AI-enabled methods.
How Patient Groups Are Outpacing Pharma In Innovation
Patient advocacy organizations driving the Buffalo Initiative operate without the legacy constraints that slow large pharma sponsors. Motivated by urgency and unburdened by bureaucracy, these groups can test new approaches faster, share learnings openly, and de-risk innovations that pharma can later scale. As Lipset put it, if the pathway can be made transparent and de-risked, pharma can do what it does exceptionally well: fast follow and scale.
This model offers a roadmap for the broader industry — one where innovation is validated at the edges and then systematically adopted at the center.
Conclusion: Adoption Is The Real Clinical Innovation
The future of clinical trials — digital, data-rich, and patient-centered — is not a distant vision. The technology to get there already exists. What the industry lacks is not more innovation, but the organizational will, structured processes, and leadership commitment to adopt and scale the innovations already within reach.
Craig Lipset’s perspective is a well-informed one, shaped by years of engagement with regulators, sponsors, patient groups, and technology developers. His message isn’t pessimistic — it’s pragmatic. Progress in clinical trials will not be defined by the tools announced at the next conference. It will be defined by whether the industry can finally close the gap between what is possible and what is actually implemented.
The technology is ready. The regulators are engaging. The industry needs to catch up.
