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Despite global clinical trials increasing by 38% over the past decade, the European Economic Area’s (EEA) global share of trials has halved over the same period. A new report by IQVIA for EFPIA and Vaccines Europe, shows that the EEA’s share of commercial trials – those sponsored by a pharmaceutical company – has reduced from 22% in 2013, to 18% in 2018 to 12% in 2023.

This translates to 60,000 fewer patients accessing a trial involving a country within the EEA and 20,000 fewer places available in EEA-only trials, meaning people living in Europe are missing out on the opportunity to access the latest medicines. The data shows significant country-level variation within the EEA; however, the number of trials has decreased in all but three countries, suggesting a systemic problem in the region.

In a major geographical shift, China has doubled its number of commercial trials since 2018, and now accounts for an 18% share of global commercial clinical trials.

Clinical trials provide patients with the earliest access to new medicines, up to 5-10 years before launch; IQVIA data estimates that EEA health systems benefit from between 1-1.5bn Euros from trial payments and drug cost savings every year; a reduction in EEA trials will therefore be felt beyond patient care.

The research suggests that Europe’s diminishing attractiveness for clinical research can be attributed to less favourable regulatory and funding environments. The EEA, for example, is slower for set up and access to trials across all therapy areas studied (oncology, infectious and rare diseases) when compared with the US. The need to conduct multi-country trials is also challenging for Europe, while the US and China in particular benefit from larger patient populations.  The report’s main findings include:

Oncology trials: There has been a relative or absolute decline in all phases of oncology trials in the EEA, which are now below 2018 levels. This contrasts to the US, who saw an increase in 2021, with levels maintained since. The fall in the EEA may be driven by factors including the In-vitro Diagnostic Regulation (IVDR), which poses operational challenges for multi-country trials in oncology and trials which are dependent on in-vitro testing. Initiatives like the EU Cancer Mission and Europe’s Beating Cancer Plan can help provide better focus in this area.

Immunisation trials: Data shows that global and EEA vaccine trials have fallen back from a Covid peak. While commercial trials are growing in numbers globally, the EEA has seen a sharp decline in numbers resulting in a drop in global share from 17% in 2018 to 8% in 2023, largely down to a decrease in Phase 3 and 4 trials. Geographically, the EEA has lost immunisation trials to Asia and Oceania, and significant variation exists within the EEA.

Rare disease trials: Despite global growth, rare disease trials in the EEA fell 4%. The report cites a lack of venture capital (VC) funding for European SMEs as a contributing factor.

Paediatric trials: Following a global trend, the number of commercial paediatric trials fell 4% in the EEA; only China has increased paediatric trial publications since the pandemic.

Cell and gene therapies (CaGT): Europe’s global share of cell and gene therapy trials has steadily decreased from 25% in 2013 to 10% in 2023. During this period, China saw a dramatic rise in CaGT trials to become the leading region with 42% share (rising from 10%), due to a favourable regulatory environment, funding streams, and strategic focus on advanced technologies.

Phase one trials: Compared to a global trend of increased phase one trials over the past 10 years – 32% to 41% – the EEA has seen a gradual decline from 19% to 14%. Phase one trials are significant as they establish a basis for further clinical development, investment and funding into a region, the detrimental impact of which is likely to be seen over the coming years.

EFPIA and Vaccines Europe are seeking action from Member States and the European Commission, to stop and reverse these trends, build on the recent Letta and Draghi reports and carry out an immediate assessment of the impact of the Clinical Trial Regulation (CTR). A range of factors are seen to enhance the clinical trial ecosystem, from minimising regulatory complexity, and simplifying and harmonising contracting processes. To build on Europe’s clinical trial capabilities, enhance the ecosystem, EFPIA and Vaccines Europe propose the following recommendations.

• Develop harmonised, agile and enabling clinical trials ecosystem that supports multi-country clinical trials.
  • Urgently deliver the promised ambition of the EU Clinical Trials Regulation to simplify, speed up, and harmonise processes across member states.
• Increase clinical trial capacity and improve infrastructure and reduce bottlenecks, through better site readiness, addressing staffing constraints, and reducing the variability in health system awareness of clinical trials.
• Implement novel, patient-centric clinical trial designs to improve delivery efficiency whilst increasing attractiveness to patients.
• Emulate Spain’s strong performance, which is built on a cycle of early policy adoption full and swift embracing of the CTR achieved through cross-stakeholder coordination, investment in major clinical trial sites, and strong commercial/non-commercial collaboration.

Nathalie Moll, Director General, EFPIA, said: “European clinical trials are hampered by a slow and fragmented research ecosystem, and current initiatives, at the current pace, are insufficient to stop and reverse a decade of decline. For Europe to be competitive it needs to function as a unified region, not as individual Member States and be supported by policies to attract global research investment. Only then will Europeans have the same opportunities to access medical breakthroughs as patients in other parts of the world”

Full study here

Notes:

Case study – Spanish success story: In 2023 Spain overtook Germany as the country with the most clinical trial starts. Over the past decade, industry investment in clinical trials in Spain has risen at an average annual rate of 5.7%, climbing from EUR 479 million in 2012 to EUR 834 million in 2022. Factors attracting investment may include the capabilities of Spain’s healthcare system, successful and timely implementation of the Clinical Trials Regulation (CTR) and an effective commercial/non-commercial trial collaboration model. Barcelona hosts a major ‘Prime Site’ for clinical trials in Southern Europe, delivering increasing number of clinical trials since 2018, and plays a major role in the ecosystem.