Europe’s clinical trial ecosystem is under pressure from rising costs, regulatory complexity, and an increasingly fast-moving Chinese biotech sector. That was the central message from an opening panel at the Panagora Clinical Trial Innovation Summit 2025, held June 26 at Roche’s Basel campus. The session brought together heads of clinical innovation from UCB, Novo Nordisk, and Novartis alongside a VC biotech advisor and the CEO of Medable, moderated by a regulatory science policy leader from Roche.
The Competitive Gap Is Widening
Europe’s clinical trial regulation was approved in 2014 but took eight years to implement. Within three years of implementation, high-level reports — including the Draghi and Letta reports — flagged the EU as an unattractive destination for clinical research. The European Commission has since prioritized reform through its life sciences strategy and the forthcoming Biotech Act, which targets regulatory, financing, scale, skills, and data and AI use.
The VC biotech advisor on the panel was direct: poorly designed trials remain the single most expensive failure in drug development. But he identified a second, less-discussed threat. Chinese biotech companies are no longer producing copies — they are generating original innovation faster and cheaper than European counterparts. Some European biotechs have responded by ceasing to publish new research targets publicly, citing cases where Chinese competitors launched competing programs within three to six months of a conference disclosure.
Critically, the Medable CEO argued that China’s speed advantage in clinical development is not technology-driven. Chinese sponsors are winning on process fundamentals — patient enrollment, site engagement, and operational execution — often while still transitioning from paper to digital systems. That distinction matters. It means technology alone will not close the gap.
DCTs Moved From Hype to Strategy
The pandemic accelerated decentralized clinical trial adoption, but the Novo Nordisk DCT specialist described that push as a “band-aid” response. Many sponsors are now pulling back and rebuilding DCT strategies from the ground up — asking not just what can be decentralized, but why and when specific elements should be.
Regulatory guidance has largely kept pace. The FDA has issued DCT guidance, ICH E6 updates and Annex 2 are incoming, and SwissMedic and the Swiss ethics committee jointly released a recommendation paper earlier this year. The Novo Nordisk representative called that collaboration between the two bodies “refreshing.” The current sticking point is ethics committees, which sometimes block trial designs that regulators have already approved.
One concrete model cited: Sweden’s trade associations have established meta-sites linked to research sites, enabling structured decentralization. The EU cross-border clinical trial initiative was also flagged as a tool for rare disease patients who cannot access trials in their home country but could in a neighboring jurisdiction.
Legacy Infrastructure Is the Real Barrier to AI
On AI adoption, the UCB clinical innovation head was unambiguous: adoption is not optional. Trial protocols are growing more complex, regulators are requesting more data, and patient willingness to participate is declining. The industry has no choice but to modernize.
The underlying problem, she noted, is legacy IT systems that perform individual functions well but do not connect across the value chain. Extracting value from AI requires foundational data infrastructure — and that transformation is large, slow, and organization-specific. There is no universal solution.
The Novartis digital endpoint lead added a workforce dimension. Finding people with the right combination of clinical, data, and engineering skills is extremely difficult. He called for “interoperable clusters” of talent across Europe — geographic hubs where expertise is concentrated, trained, and shared — drawing a parallel to data interoperability efforts already underway in the industry.
Early Regulator Dialogue Is Underused
Panelists agreed that sponsors consistently underuse one available tool: proactive regulator engagement. The Novo Nordisk DCT specialist argued that the industry defaults to submitting protocols and layering on technology afterward — the wrong sequence. Regulators at both the FDA and EMA have explicitly invited sponsors to engage early and often, but sponsors have been slow to take them up on it.
The Novartis panelist confirmed that early engagement has worked in practice. Conversations with the EMA and FDA ahead of late-stage trials helped clarify what digital endpoint evidence would be required for registrational studies — saving time and reducing uncertainty downstream. The UCB representative noted the FDA recently piloted a faster scientific review process, a sign that regulators are also investing in their own operational transformation.
The session closed with each panelist offering a single priority. The through-line: Europe needs to move faster, build talent infrastructure, streamline legacy systems, and engage regulators as partners rather than gatekeepers. The Biotech Act, expected to take shape next year, will be the next real test of whether that ambition translates into policy. If the combined device and CTA assessment pilot launching later in 2025 delivers measurable time savings, it could signal the pace of change to come.
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
