The clinical trial landscape in Europe has changed substantially since the COVID-19 pandemic. The crisis disrupted ongoing studies and made patient recruitment difficult, but it also pushed forward innovations that are now part of the region’s long-term research framework. Sponsors today are working within a more unified regulatory environment, adopting decentralised and hybrid models, relying more on real-world data, and facing stronger links between trial results and market access decisions.
A key development is the implementation of the EU Clinical Trials Regulation (CTR), which became applicable in 2022 and must be fully adopted by 31 January 2025. From that date, all new and ongoing trials in the European Union must be managed through the Clinical Trials Information System (CTIS). This system replaces the old country-by-country approach with a single application process and harmonised safety reporting. For sponsors, the CTR promises efficiency but also requires a shift in practice. Teams must become familiar with CTIS workflows, assign clear internal roles, and manage transparency since many submitted documents will be made public under new publication rules adopted in 2024.
Trial conduct has also evolved. During COVID-19, regulators allowed remote tools such as electronic consent, telemedicine visits, and home drug deliveries. These emergency measures are now being formalised. Under the joint Accelerating Clinical Trials in the EU (ACT EU) programme, European authorities have issued guidance supporting decentralised clinical trials. National agencies, such as Spain’s AEMPS, have published practical instructions on how to manage patient safety, home health visits, and remote data capture. As a result, hybrid designs are becoming the default approach, blending site-based assessments with remote elements to reduce patient burden and improve trial inclusivity.
Real-world evidence has taken on greater importance. The EMA’s DARWIN EU network, launched in 2022 and fully operational in 2024, is now used to generate large-scale studies based on electronic health records and other health data sources across Europe. Regulators are increasingly requesting real-world data to complement traditional trial evidence, particularly for long-term safety and effectiveness assessments. Sponsors need to plan their data strategies early, considering which registries are available, how to assure data quality, and how to meet European data protection requirements.
Another change is the closer connection between research and reimbursement. The EU Health Technology Assessment Regulation introduces Joint Clinical Assessments starting in January 2025. Oncology medicines and advanced therapy products will be the first to undergo this process, which provides a single EU-level evaluation to inform national payer decisions. This means sponsors must now design studies that meet both regulatory and payer needs, including the use of relevant comparators and patient-centred endpoints. A trial that satisfies regulators but does not answer payer questions risks delays in reimbursement even after approval.
Despite these reforms, Europe’s competitiveness has declined. EFPIA data show that the region’s share of global industry-sponsored trials fell from around 22 percent in 2013 to 12 percent in 2023. China has doubled its share, and the United States remains dominant. Spain has been a bright spot in Europe, consistently performing well thanks to efficient approvals and strong recruitment networks. For Europe as a whole, the success of CTR and CTIS will depend on whether they can deliver faster and more predictable trial start-up.
The United Kingdom, no longer under EU rules, has moved in its own direction. In 2024, it introduced legislation to create a more flexible system with proportionate oversight and shorter timelines. Sponsors must now manage both EU and UK frameworks, but the UK’s streamlined approach may attract innovative or early-phase research.
Looking ahead, Europe’s clinical trial environment is becoming more centralised, more digital, and more transparent. Sponsors will need to build CTIS expertise, adopt hybrid trial models as the standard, integrate real-world evidence into development plans, and align study designs with payer as well as regulatory needs. Those who adapt will benefit from faster approvals and better market access, while those who do not risk delays and lost competitiveness.
For Tigermed EMEA, these changes represent both a challenge and an opportunity. The company can support sponsors by helping them navigate the CTR and CTIS, design hybrid protocols adapted to national guidance, and integrate real-world evidence strategies into development programs. By aligning studies with both regulatory and payer expectations, Tigermed EMEA is well positioned to guide clients through the new European landscape and ensure their innovations reach patients more efficiently.
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