Feb 15, 2013, was International Childhood Cancer Awareness Day, and on Feb 20, 2013, the European Society of Paediatric Oncology (SIOPE) held its yearly high-level meeting at the European Parliament (Brussels, Belgium) to mark this occasion. The focus of the meeting was the proposal by the European Commission (EC) for the European Union (EU) Clinical Trials Regulation (CTR), which is being assessed by the member states and European Parliament. Once passed, the CTR will replace the tight but disproportionately regulated and much-criticised EU Clinical Trials Directive 2001/20/EC (Directive).