Clinical Trials

Clinical trials are one of the most critical, expensive and time-consuming stages of the drug development process. An effective and harmonised regulatory framework is essential – not only to maintain the EU’s global competitiveness in pharmaceutical innovation, but also to ensure patients with unmet medical needs can access the latest scientific breakthroughs.

Multi-country clinical trials are especially critical, enabling medicine developers in Europe to scale their efforts and compete with global leaders like the US, China and other global competitors.

However, ongoing regulatory fragmentation and operational complexity continue to make the EU a less attractive location for conducting clinical research, as also underlined in both Letta and Draghi reports.

Why clinical trials matter

Clinical trials are the foundation of modern medicine. They bring together researchers, doctors, and patients to evaluate new medicines in real-world settings.

For patients, they often mean early access to life-saving therapies – up to 5-10 years before these medicines are available on the market. For those facing rare or advanced diseases, trials may be the last treatment option.

Beyond individual care, trials benefit entire health systems:

€1–1.5 billion from trial payments and drug cost savings across the EU each year.
Research-active hospitals experience lower staff turnover and improved morale.
They also have lower mortality rates, even for patients not directly participating in trials.
Clinical trials play a vital role in advancing medical knowledge and provide health systems with experience of novel treatments prior to approval.

For Europe, clinical trials are a pillar of scientific leadership:

€50 billion invested in R&D in 2023.
130,000 people employed in pharma R&D across Europe.
A thriving ecosystem that attracts biotech and life sciences companies.

A fragmented ecosystem is costing Europe its edge

Despite a 38% increase in global clinical trials over the past decade, Europe’s share has dropped from 22% in 2013 to 12% in 2023. That’s 60,000 fewer clinical trial places for European patients.

Particularly worrying is the trend for advanced therapeutics such as cell and gene therapy trials. China’s share has soared to 42%, while Europe’s has fallen from 25% to just 10%. This is not coincidental – favourable regulatory frameworks and strategic investments have transformed Asia into a new scientific hub.

Europe is losing ground due to a fragmented clinical trial ecosystem. While a few countries perform well, most of them have seen trial numbers decline, pointing to structural, not local, issues. If Europe does not act quickly, the trend will accelerate, with more R&D and advanced manufacturing relocating to the US and Asia.

From Vision to Action: strengthening Europe’s clinical trials ecosystem

EFPIA’s Vision for 2030+ wants to position Europe as a global leader in faster, smarter, and more patient-centred clinical trials. To achieve this, Europe must uniformly implement the Clinical Trials Regulation, optimise the Clinical Trials Information System (CTIS), and streamline processes across Member States. A key enabler will be harmonised, efficient multi-country trial processes, including coordinated ethics reviews and cross-border patient participation.

Innovation must also be at the core of our efforts to reverse recent negative trends. EFPIA champions the adoption of decentralised and data-enabled trial models, inclusion of diverse patient populations, and stronger public-private partnerships to support sustainable research infrastructure. Initiatives such as EU-X-CT exemplify the collaborative spirit needed – bringing together stakeholders to simplify trial processes and improve clinical research performance across Europe.

With the upcoming EU Biotech Act, there is a unique opportunity to reverse the current decline. EFPIA is committed to working with policymakers, regulators and stakeholders to realise this vision and secure Europe’s place at the forefront of global clinical research.