Europe's share of clinical trials falling, with China rising

The proportion of commercially sponsored clinical trials run in Europe almost halved over the last 10 years and is now trailing China, whose share has doubled in the same period.

That is the finding of a new study carried out by data specialist IQVIA and the European Federation of Pharmaceutical Industries and Association (EFPIA) trade organisation, which estimates that around 12% of trials were run in the European Economic Area (EEA) last year, compared to 18% in China.

In 2018, the EEA accounted for 18% and China made up around 9%, with the massive increase in the latter in a few short years attributed to a simpler regulatory environment and better access to funding. The trend is particularly apparent in phase 1 and cell and gene therapy (CGT) trials, where Europe has seen a marked decline in new starts.

There has also been a loss of share from Europe to North America, even though that region has also seen a decline in trials over the last 10 years from 26% to 17% in 2023. The changes come against a backdrop of a 38% increase in the total number of study starts in that period.

EFPIA said that, overall, the trend "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 EEA still holds up fairly well in large-scale, multi-country studies, but has still seen a decline from 23% to 19% since 2018, according to the report.

"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," said EFPIA director-general Nathalie Moll.

Recent measures like the EU Clinical Trial Regulation (CTR), which came into effect at the start of 2023, have not been implemented quickly enough to counteract slow set-up times and lacklustre access to trials compared to other regions, including the US, says the analysis.

"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," added Moll.

The findings echo comments made by two clinical research specialists earlier this year, focusing on the UK sector, which said red tape is stifling early-phase clinical research and making it harder to advance novel therapies through development.

Among the weak spots in the European clinical trial ecosystem cited in the report are cancer studies, held up by regulations on the use of in vitro diagnostics that present operational challenges to sponsors, as well as vaccine, rare disease, paediatric, CGT, and phase 1 studies.

Notably, Spain is bucking the trend, outperforming the rest of the EEA in terms of new starts and overtaking Germany as the country carrying out the most studies, which EFPIA and IQVIA suggest is a result of investment in new research facilities, rapid compliance with the CTR changes, and an effective commercial/non-commercial trial collaboration model.