The conduct of multinational clinical trials - vital to ensure optimal treatment for children with cancer – has been seriously impeded by the exaggerate bureaucracy deriving from the EU Clinical Trials Directive (CTD). Although the objective of the CTD was to standardise the regulation and quality of trials, there was a lack of coordination and significant duplication of efforts and resources invested by the clinical trial groups to meet its 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.
Today, there is a potential for these limitations to be reversed by the proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use in Europe, meant to repeal Directive 2001/20/EC and currently debated by national ministries and Members of the European Parliament.
SIOPE has been invited by the European Commission to several meetings as a key stakeholder in this revision process, and we are deeply involved in the discussions that followed the publication of the new Regulation, making sure that our priorities are correctly represented (also by regularly consulting the European Clinical Research Council for paediatric oncology (ECRC), the collective voice of European clinical trials’ groups and paediatric oncology national societies).