The delay in the implementation of the Life Science Strategy represents a barrier to Europe’s trial eco-system and affects the health of European citizens, particularly small populations such as paediatric and people living with orphan diseases.
A report supported by a broad group of stakeholders—including academic and industry sponsors, investigators, and professional societies, was published presenting a number of proposed actions and solutions which must be taken to support clinical trials in the EU.
The report tackles areas including difficulties in recruiting patients, regulatory simplification, harmonisation and streamlining, high administrative burden and financial challenges that researchers face.
While welcoming the recent Life Science Strategy (LSS) announcement, which will facilitate and enhance the conduct of multi-country clinical trials in Europe, stakeholders 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.
Dr. Donato Bonifazi, member of the EPTRI Board of Directors and representative of TEDDY Network, an EPTRI member, 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, i.e., paediatric and rare diseases patients.”
This report aims to call attention to the unmet needs of the implementation of clinical trials across Europe, particularly the ones regarding the paediatric population and people living with rare diseases. It represents a joint action to push for better therapeutic options in the EU.