As China and the US attract an increasing share of commercial clinical trials, Europe is fighting to reclaim its spot as a global research leader. While Europe has world-class hospitals and experienced regulators, it has struggled with a complicated and fragmented approval system that has pushed trial sponsors elsewhere. To turn the tide, the EU and national regulators are working together to simplify rules, use real-world patient data, support decentralised (more patient-friendly) trial models, and show more flexibility overall. By making these changes, they hope to win back researchers, bring innovative treatments to patients faster, and keep Europe competitive on the global stage. Here are four trends to watch.
Big Steps Towards Regulatory Harmonisation
Europe has a long tradition of clinical research excellence, with leading hospitals, strong academic centres, and top regulators. Yet despite these advantages, complicated and fragmented rules have pushed many global trials elsewhere. Between 2013 and 2023, Europe’s share of commercial clinical trials dropped sharply from 22% to just 12%, according to EFPIA and IQVIA.
To fix this, the EU launched the Accelerating Clinical Trials in the EU (ACT EU) initiative in 2022. The goal: make Europe a more attractive, unified place to run trials. A big milestone was the EU Clinical Trials Regulation (CTR), which came into force in 2022 to simplify and speed up approvals across member states. So far, CTR has cut trial approval times by an average of 25 days.
“We have made great progress towards the broad goal of ACT EU: better and more impactful clinical trials in Europe,” said Peter Arlett, head of Data Analytics and Methods at the European Medicines Agency (EMA).
Europe also rolled out the Clinical Trials Information System (CTIS), a centralised online portal that makes submissions easier and improves data transparency.
Another important step is the COMBINE initiative, which tackles the tricky overlap between drug and device regulations. “Clinical trials involving both medicinal products and medical devices often sit at the intersection of different regulations, creating uncertainty and, at times, contradictory guidance for researchers,” explained Marianne Pilgaard, CEO of Trial Nation in Denmark. “COMBINE brings together national regulators across the EU to harmonise their approaches and ensure that applicants receive coherent, non-conflicting advice.”
Leveraging Real-World Evidence (RWE)
Europe is also betting big on real-world evidence (RWE) — data gathered from actual patient experiences outside traditional clinical trials, like hospital records, health insurance data, and wearable devices. This approach offers a more complete picture of how treatments work in everyday life.
Recognizing this, the EMA and the European Medicines Regulatory Network (EMRN) launched DARWIN EU, a network that connects real-world healthcare databases from across Europe. Right now, DARWIN EU includes 20 data partners from 13 countries and covers data from about 130 million patients.
According to EMA’s Peter Arlett, “From 2025, we are contracted to a ceiling of 140 studies, which is an absolute game changer. As far as I’m aware, no other organisation in the world has ever done RWE studies in those kinds of numbers before.”
Local regulators are also moving fast to integrate real-world data (RWD). Nils Falk Bjerregaard, director general of Denmark’s national regulator (DKMA), pointed out, “RWD is especially critical in areas where traditional clinical trial models are less feasible. For example, in rare diseases and personalised medicine where small patient populations limit the scalability of standard randomised studies.”
Last year, DKMA completed 15–20 RWE projects and aims to more than double that number this year. These efforts also align with the European Health Data Space (EHDS), launched in 2024, which aims to make it easier to share and use health data across Europe.
Pharma companies are on board, too. “We’re investing heavily in real-world evidence,” said Montse Jansà, GM and managing director of Merck Denmark. “Real-world data captures outcomes across large, diverse patient groups, giving us a much clearer picture of how treatments perform in everyday practice. This not only boosts clinical confidence but also informs new indications and supports broader, evidence-based decision-making.”
Embracing Decentralisation
Europe is also pushing hard to make clinical trials more patient-friendly through decentralised models. These trials use telemedicine, home visits, wearables, and apps to reduce the need for patients to travel to hospitals. In 2023 alone, over 700 European trials included these elements.
Under the ACT EU initiative, the EU published recommendations to help guide decentralised clinical studies, aiming to improve accessibility and make participation easier for patients across different regions.
National regulators are fully on board. “DKMA has also focused on facilitating decentralised clinical trials to ensure that studies reach the patient populations who most need them,” said Nils Falk Bjerregaard, director general of Denmark’s Medicines Agency. “National guidelines have been developed to support this shift, and the response from clinical researchers has been overwhelmingly positive.”
Decentralisation is seen as a way to boost diversity in trials and make studies more representative of real-world populations. By reducing barriers for patients, Europe hopes to improve trial enrollment and generate more relevant data on how treatments work in everyday settings.
Pro-active Regulatory Stance
As Europe works to strengthen its clinical trial environment, individual countries have taken big steps to move faster and make themselves more attractive to global sponsors.
Among Europe’s top ten clinical trial destinations, Spain has led the charge, becoming the first country to fully adopt the EU Clinical Trials Regulation and adapt its local processes to match. This early move, supported by the Spanish Agency of Medicines and Medical Devices (AEMPS), has helped position Spain as Europe’s top clinical trial destination.
France has also stepped up, introducing its Health Innovation 2030 plan to support research and improve trial timelines. Thanks to these efforts, average approval times dropped from 204 days in 2019 to 160 days in 2024 — a clear sign of progress.
Germany is making similar changes. Its new Medical Research Act is designed to accelerate approvals, simplify contract negotiations, and improve coordination between stakeholders.
Other, smaller, nations are following suit. Marianne Pilgaard, CEO of Denmark’s Trial Nation, recently told PharmaBoardroom, “We’ve updated our guidelines and streamlined processes to make Denmark an even more attractive place to run trials. We’re already seeing strong interest from international sponsors, which is very encouraging.”
