We welcome the proposal for a Clinical Trials Regulation released by the European Commission. The Regulation appears to improve the legislation associated with running clinical trials. This will give clinicians and researchers a better framework for developing and testing treatments, to benefit patients across Europe, while maintaining the high standards of patient safety that currently exist in European clinical research. The harmonisation of clinical trials legislation and the streamlining of the application process for starting trials should particularly benefit the set up and running of multi-national trials in Europe.