EU Clinical Trials Directive (2001/20/EC)
Last update on: 04/09/2009
Since the EU directive has been adopted into national law in 2001, the necessary requirements in trials for children have increased – even in standard therapies. Now, public utility institutions must meet similar requirements to those found in the pharmaceutical industry. Special infrastructure and organisational structures are now required, in order to continue to provide child-friendly, legal, methodically valid and efficient trials for children.
„We observed that documentation expenses and the bureaucracy have increased drastically to conduct cost-efficient clinical studies since 2004 which has made it impossible for us paediatric oncologists to conduct cost-efficient clinical studies, requiring additional funds which are difficult to acquire at this time.“
Prof. Angelika Eggert,
successful international childhood cancer researcher and coordinator of an EC-funded research project entitled „EET-Pipeline“, dedicated to study rare tumours in children
Interview recorded during the international symposium on established successes and future challenges in paediatric oncology, May 15-17, 2008, Vienna
Find the interview in the material repository
There is a Lack of Funds
There is a need for corresponding financial funds for paediatric cancer research in order to be able to run both clinical study centres as well as to maintain national and international research networks.
Only in this way will it be possible to further improve the survival chances in children and adolescents.