EU Clinical Trials Directive 2001/20/EC
The European Commission recently issues a Public Consultation in December 2009 on the EU Clinical Trials Directive (EU CTD) 2001/20/EC of which SIOPE responded to.
As pointed out in the Consultation, although the objective of the CTD is to standardise the regulation and quality of trials, there is rather a lack of coordination and significant duplication of efforts and resources invested by the clinical trial groups to meet EU CTD requirements. In particular, the CTD has had a disproportionately negative effect on trials in childhood cancer where there has been the greatest variability in national interpretation of the Directive.
Paediatric medicines was explicitly included in its own right within the Consultation, a feature that was appreciated by SIOPE.
While each major type of childhood cancer is individually rare, 1 in 500 will be affected by cancer during childhood. This represents 1% of all forms of cancer. Despite favourable survival rates, cancer remains the leading cause of death from disease in children and young adults. Therefore, multinational clinical trials are vital to ensure optimal treatment for each young person diagnosed with cancer.
It is clear that clinical research should not be considered a luxury but rather a necessary tool to ombat the burden of cancer. However, the current bureaucratic workload of trial activation is much too high for the many rare diseases that comprise the childhood cancers. Moreover, the rare nature of the disease results in investigator-led trials due to the lack of commercial
sponsorship. Indeed, many non-commercial organisations are still unwilling to undertake the role of sponsor at a pan-European level for multinational trials in children.
You can download the relevant documents here: