Clinical Trials Are Fleeing Europe: What Needs to Change?

Europe, particularly France, is becoming less attractive to pharmaceutical companies conducting clinical trials due to excessive bureaucracy that delays processes, according to Leem (Les Entreprises du Médicament), an association representing the interests of pharmaceutical companies in France. After controversial decisions by US President Donald Trump in the scientific field, such as budget cuts and restrictions on certain terms, some believe that scientists frustrated by unfulfilled promises in the United States may seek funding in Europe instead.

However, despite its potential to reclaim its status as a scientific hub, Europe continues to lose its ground.

Leem’s annual survey for 2025 revealed that Europe is no longer a top destination for clinical trials. In 2024, Europe hosted only 19% of global clinical trials, approximately 1900, lagging far behind Asia (60%) and the Americas (28%). Some trials spanned multiple regions.

Even European pharmaceutical companies are struggling, conducting only 17% of global trials compared with 53% by Asian firms and 27% by US companies.

Bureaucracy vs Public Support

Within Europe, France ranks third in terms of clinical trial volume, behind Spain and Germany.

Leem stated that only 10 years ago, France was the European leader in clinical research. France’s position is supported by its impressive performance in oncology research — 41% of clinical trials conducted in France focus on cancer — and its robust public sector involvement. The country leads Europe in mixed public-private trials.

However, France is losing momentum in diabetes research, ranking fifth in Europe, and is facing significant bureaucratic challenges. On average, it takes 104 days in France to authorize a clinical trial and 184 days to enroll the first patient, compared with 162 days in Spain.

Leem has urged France to follow Germany and Spain by simplifying clinical trial regulations and advocated for “fast-track” procedures to accelerate trials, particularly when no therapeutic alternatives are available.

Streamlining and Modernization

Leem also recommended adopting a “contractualization” approach, similar to Germany’s, by introducing standardized clauses in contracts to simplify administrative processes. Additionally, the association calls for decentralization and digitalization of clinical trials to bring them closer to patients.

Leem hopes the long-delayed economic simplification bill, under discussion for nearly a year, will provide laboratories with greater flexibility.

At a broader level, Leem stressed the need for clearer regulations and harmonized procedures across member states. The European Union should aim to enable the launch of clinical trials within a month.

“France and Europe have significant potential for clinical research, but administrative burdens and regulatory complexities hinder our competitiveness. Swift action is needed to simplify, accelerate, and harmonize processes to ensure French patients have rapid access to innovations,” concluded Thierry Hulot, president of Leem.

This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.