Clinical Trials Regulation: The adopted text


It is only thanks to clinical trials if the cure-rate of childhood cancers made considerable progresses over the past 40 years, and clinical trials are vital to improve the availability and the outcome of treatments for children and adolescents with cancer. To advance research however is not easy; since the creation of SIOPE, our efforts focused on the current bureaucratic workload to trial activation. Paediatric oncology clinical research in Europe is mainly investigator-led and sponsored by public universities, that often cannot afford the high costs and lengthy bureaucracy linked to multinational trials in children. This exaggerate bureaucracy derives from theEU Clinical Trials Directive of 2001, which resulted in a severe negative impact on childhood cancer trials, due to the greatest variability in the national interpretation and a significant duplication of efforts and resources invested by the clinical trial groups to meet its requirements.

On 2nd April 2014, a newRegulation finally repealed this Directive. SIOPE intervened in several European institutions' meetings as a key stakeholder in the revision process of the Directive and, currently, we are deeply involved in the discussions that followed the adoption of the new Regulation. SIOPE will continue to make sure that the priorities of paediatric oncology professionals are always correctly represented, also by regularly consulting the European Clinical Research Council for paediatric oncology, the collective voice of European clinical trials’ groups and paediatric oncology national societies.

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