European journal of cancer : official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
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Clinical trials for children with cancer have been particularly hard hit by the introduction of the EU Clinical Trials Directive in 2004. Largely investigator-led and lacking in commercial sponsorship, they have struggled to find the resources necessary to comply with the complex bureaucracy. ⋯ Insurance costs have increased a 100-fold with no increase in actual risk between consecutive trials from the same study group. Issues raised at the recent conference held to reappraise the operation of the Directive are summarised to emphasise the particular issues for trials in children with cancer.