CVBF joins industry coalition warning of declining research opportunities across Europe

Donato Bonifazi, CEO of CVBF, Coordinator of EPTRI, and representative of TEDDY, participated in the 24 March roundtable that brought together academic and industry sponsors, investigators, and professional societies to address the mounting challenges facing European clinical research. The subsequent report outlines issues that threaten Europe’s position as a global leader in medical innovation.

Despite the introduction of the Clinical Trials Regulation (CTR) in 2022, designed to streamline processes across member states, the report reveals persistent fragmentation. Countries continue to impose additional national requirements beyond EU legislation, contradicting the regulation’s core harmonization objectives. This is particularly problematic for investigator-initiated trials, paediatric studies, and rare disease research. The impact is most severe in paediatric medicine, where new drug approvals lag nearly a decade behind adult authorizations.

The coalition’s report underscores the need for immediate action to revitalize Europe’s clinical research ecosystem. Key recommendations include streamlining regulatory processes, reducing administrative burden, improving cross-border coordination, and ensuring adequate funding for innovative research approaches.

According to the press release recently issued by EFPIA, a comprehensive analysis of Europe’s clinical trial landscape reveals a system in crisis, with stakeholders across the sector issuing an urgent call for reform following a detailed roundtable discussion held in March. The findings paint a stark picture: despite a 38% global increase in clinical trials over the past decade, Europe’s share has plummeted from 22% in 2013 to just 12% in 2023, representing 60 000 fewer clinical trial opportunities for European patients.

Our CEO stated: “The Life Science Strategy should prioritise dedicated funding and innovative approaches that support the translation of scientific advances into real-world health solutions, targeted to solve the unmet medical needs and to accelerate availability of new therapies, diagnostics, and devices for the underserved populations, including paediatric and rare disease patients.”