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 miss 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 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 is 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 a 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, and enhance the
ecosystem, EFPIA and Vaccines Europe propose the following recommendations.
v Develop harmonised, agile and enabling clinical trials ecosystem that supports multi-country
clinical trials.
o Urgently deliver the promised ambition of the EU Clinical Trials Regulation to
simplify, speed up, and harmonise processes across member states.
v Increase clinical trial capacity improve infrastructure and reduce bottlenecks, through
better site readiness, addressing staffing constraints, and reducing the variability in health
system awareness of clinical trials.
v Implement novel, patient-centric clinical trial designs to improve delivery efficiency whilst
increasing attractiveness to patients.
v 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”