A group of organisations working in the European clinical trial sector, including EATRIS, are today issuing a warning to policy-makers, that without urgent implementation of the Life Science Strategy, Europe’s clinical trial eco-system is in a perilous situation.
The group- including academic and industry sponsors, investigators, and professional societies – formed earlier this year to review the state of clinical trials and to discuss joint solutions to ongoing challenges in Europe.
A subsequent report sets out a number of actions which can 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 stress the urgent need for better regulatory alignment across Member States. Fragmented implementation of the Clinical Trials Regulation (CTR) has added barriers for clinical studies, and inconsistent assessments and complex requirements continue to delay trial launches, and increase administrative burden.
There is broad consensus on the need for a more effective framework; 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) to facilitate and enhance the conduct of multi-country clinical trials in Europe [published 2 July 2025]. However, they remain concerned that the speed in which the proposals will be implemented will not be swift enough to mitigate the threat of clinical trials leaving Europe for other regions of the world.
Previous EFPIA data shows that there are 60,000 fewer clinical trial places available for Europeans since 2013. Many industry-sponsored trials have moved to the US and China in recent years, due to better patient access, supportive policies and less red tape, meaning trials are easier to facilitate.
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 decline. 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 revive the clinical research ecosystem in Europe.”
Donato Bonifazi, Secretary, TEDDY – European Network of Excellence for Paediatric Research, 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.”
List of co-signatory organisations
- ECRAID: European Clinical Research Alliance for Infectious Diseases – https://www.ecraid.eu/
- ECRIN: European Clinical Research Infrastructure Network – https://www.ecrin.org/
- EATRIS: European Infrastructure for Translational Medicine – https://eatris.eu/
- EFPIA: European Federation of Pharmaceutical Industries and Associations – https://www.efpia.eu/
- EHA: European Haematology Association – https://ehaweb.org/
- EORTC: European Organisation for Research and Treatment of Cancer – https://www.eortc.org/
- EuropaBio: European Association for Bioindustries – https://www.europabio.org/ o hollandbio: https://www.hollandbio.nl/
- bioMerieux: https://www.biomerieux.com/corp/fr.html o BioMarin: https://www.biomarin.com/
- EUCOPE: European Confederation of Pharmaceutical Entrepreneurs – https://www.eucope.org/
- ESMO: European Society For Medical Oncology – https://www.esmo.org/
- ESPGHAN: The European Society for Paediatric Gastroenterology Hepatology and Nutrition – https://www.espghan.org/
- The Coalition for Reducing Bureaucracy in Clinical Trials – https://bureaucracyincts.eu/
- TEDDY: European Network of Excellence for Paediatric Research – https://www.teddynetwork.net/
- Vaccinopolis (innovative vaccine research centre), European Plotkin Institute for Vaccinology, University of Antwerp
- Vaccines Europe – https://www.vaccineseurope.eu/
