Forget More Clinical Tech, We Need More Adoption
By Dan Schell, Chief Editor, Clinical Leader
At the Clinical Leader booth on the exhibit hall floor at SCOPE Summit, Craig Lipset offered me a candid look at where innovation in clinical trials is actually moving — and where it keeps getting stuck. As co-founder of the Decentralized Trials & Research Alliance (DTRA), he sits at the intersection of regulators, sponsors, and technology developers trying to modernize trial execution. During our conversation, he made it clear that innovative tools exist, and regulators are engaging, but it’s this industry’s unwillingness to change (for whatever reason you want to choose) that is putting the kibosh on adoption and — dare I say — widespread innovation.
How Will The FDA View Trial Tech Now?
One bright spot of our conversation was when Lipset talked about a recent DTRA workshop with the FDA focused on inspection readiness and digital trial tools. He described the agency’s participation as encouraging. “I think it’s very revealing that the agency is engaged,” he said. “They want to demystify [how tech and innovations] will be viewed … so people don’t have to be worried about what inspectors will say.”
With fewer inspectors today and discussion of aggressive rehiring, Lipset sees an opportunity for inspections to evolve alongside technology. Instead of questioning digital tools, inspectors may soon question the lack of them. “What happens if inspectors flip the conversation?” he asked regarding the age-old debate over using paper vs. digital tools as part of studies. Instead of asking why you’re using newer digital data collection techniques and systems, what is they start asking why you’re still using paper? I mean, electronic informed consent, for example, provides time stamps, version tracking, and auditability — capabilities paper can’t match. And with more high-profile lawsuits regarding sites that falsified paper source docs, I can’t imagine we won’t start seeing more of a exodus from paper.
Walking the exhibit hall at SCOPE, Lipset saw what everyone sees: AI everywhere. But he questioned whether the industry is truly prepared to use it. “A cynic could look and say, for God’s sake, we still do paper informed consent. Who are we kidding?” he said. “Our ability to adopt and embed true innovation is lackluster.”
He joked about posting a cartoon showing “agentic robots standing around a fax machine sending paper informed consent,” a reminder that new tools mean little without operational change. He believes pharma excels at managing drug development pipelines but fails to manage process innovations the same way. “If process innovation went through a funnel like therapeutics do, we’d see a funnel that is constipated,” he said. “What’s the last thing that got through globally at enterprise scale? EDC?” The industry, he argued, must stop chasing the next shiny technology and instead focus on scaling what already works.
Amen, brother. Amen.
DCTs, Rare-Disease, And The Industry’s Future
I was curious about how DTRA has evolved since being founded a few years ago. Lipset actually said what I believe is true: “I’ll have some groups tell me decentralized is now normalized,” he said. “Others tell me decentralized is toxic — they can’t sell it.”
He added that pharma sponsor membership in DTRA continues to grow, while some vendors struggle to align offerings with sponsor demand. He sees a disconnect between what suppliers think buyers want and what they actually need.
He wrapped up our interview with an explanation of the Buffalo Initiative, a nonprofit effort advancing therapies for ultra-rare diseases using platform trial approaches and AI-enabled methods. Patient groups often believe pharma will adopt promising therapies once early development milestones are reached. “That just doesn’t happen,” Lipset said. Without legacy constraints and driven by urgency, these groups can test new approaches faster and share learnings openly. “If we can de-risk it and make it transparent,” he said, “pharma can do what they do really well — fast follow and scale.”
Did most of what he told me during our discussion surprise me?
Nah.
But there’s no doubt Lipset is “plugged in.” He’s been in this industry for decades, but more importantly, he frequently speaks with a diverse set of people and professionals. That’s why I always appreciate his perspectives on hot — and sometimes tried-and-true — topics.
Will the future of clinical trials be digital, data-rich, and patient-centered? Man, I hope so. But getting there … that’s going to be a tough road. And “progress” won’t be defined by just new tools alone. It will depend on whether the industry can finally adopt, implement, and scale the innovations already within reach.