This note considers the difficulties LERU members have experienced when conducting clinical trials as part of FP7 Co-operation and the Joint Technology Initiative's Innovative Medicines Initiative (IMI) projects. This paper examines these issues and makes a series of recommendations for actions by the European Commission (EC) to improve the provisions for conducting clinical trials in EU projects. Such actions would be very timely, not only in readiness for the beginning of Horizon 2020 in 2014, but also in light of the current revision of the EU Clinical Trials Directive.