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Clinical trial community... Clinical trial community seek urgent implementation of Life Science Strategy, as research becomes increasingly endangered
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Clinical trial community seek urgent implementation of Life Science Strategy, as research becomes increasingly endangered

16.07.25

A broad group of organisations, working in the European clinical trial sector, have issued a warning to policy makers, that without urgent implementation of the Life Science Strategy, Europe’s trial eco-system faces a perilous situation.

The broad group of stakeholders—including academic and industry sponsors, investigators, and professional societies—formed earlier this year to review the state of clinical trials in Europe and discuss joint solutions to ongoing challenges.

The report published today [16 July] sets out a number of actions which should be taken to support clinical trials in the EU. It highlights the issues faced by researchers, including difficulties in recruiting patients, regulatory complexity, high administrative burden and financial challenges.

Participants stressed the urgent need for better regulatory alignment across Member States. Fragmented implementation of the Clinical Trials Regulation (CTR) added barriers for clinical studies, inconsistent assessments, and complex requirements continue to delay trial launches and increase the administrative burden.

There is broad consensus on the need for a more effective framework, and one which embraces streamlined and risk-based approaches, particularly for investigator initiated, low-intervention and paediatric trials. A framework that strengthens trust and coordination between ethics committees and national regulatory authorities whilst also helping to recruit and retain talented researchers.

The group supports the pragmatic proposals contained in the recent Life Science Strategy (LSS) announcement to facilitate and enhance the conduct of multi-country clinical trials in Europe [2 July 2025], however, they remain concerned that the speed in which the proposals could be implemented will not be fast enough to mitigate the threat of more clinical trials leaving Europe for other regions of the world.

Previous EFPIA data shows that there are around 60,000 fewer clinical trial places for Europeans since 2013 with many industry-sponsored trials moving to the US and China in recent years, where better patient access, supportive policies and less red tape and mean trials are easier to facilitate than in EU Member States.

Nathalie Moll, Director General, EFPIA, said: “The Life Science Strategy could not be more timely. Turning these proposals into concrete actions is what really matters for patients in Europe as the number of clinical trial opportunities continue to fall rapidly. Policy makers need to work closely with partners to bring meaningful reform and a stronger clinical trial ecosystem in Europe.”

Professor Martin Dreyling, European Haematology Association, said: “Despite the ambition and best intentions of the EU clinical trials directive, clinical research activities in Europe have continued to significantly decrease. Administrative burdens have increased, but more importantly we believe that patient safety has been impacted. Policy makers need to refocus initiatives to improve patient-centred study designs and to begin to revive the clinical research ecosystem in Europe.”

Donato Bonifazi, Secretary, TEDDY, said: “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.”

Notes to editors

Annex – List of organisations represented at the Roundtable

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