Advocating for better research and clinical trials in the EU
TEDDY Network is happy to announce our participation in a roundtable held on March 24 to review the state of clinical trials in Europe and discuss joint solutions to ongoing challenges. The roundtable counted with academic and industry sponsors, investigators, and professional societies.
The conclusions of this roundtable were compiled in a report setting out a number of actions that can be taken to support clinical trials in the EU, agreed among the group of participants to the roundtable. 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.
Participants welcome the recent Life Science Strategy (LSS) announcement, which will facilitate and enhance the conduct of multi-country clinical trials in Europe, 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.
In the context of the press release agreed among the group and published on July 16, Dr. Donato Bonifazi, representing of TEDDY Network, 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.”
TEDDY Network will continue to advocate for better therapies and healthcare options for the paediatric and orphan populations.