Harmful impact of EU clinical trials directive

Editor—Hemminki and Kellokumpu-Lehtinen show the impact of the EU Clinical Trials Directive and the resulting additional cost and bureaucratic delays on cancer drug research.¹ It has become almost impossible for academic researchers to initiate and conduct pharmaceutical trials without the involvement of a pharmaceutical company, particularly in areas that do not attract much funding or involve a drug that is close to the end of or outwith patent protection.

We recently abandoned attempts to conduct a trial of an alerting drug in patients with fibromyalgia. The Trials Directorate of the Medicines and Healthcare products Regulatory Agency (MHRA) was as helpful as possible within the limits of the regulations, but the cumulative burden of regulatory requirements and delays, both locally and nationally, resulted in the modest grant from the pharmaceutical company being almost exhausted before we could even begin to contemplate the recruitment of a single patient.

We endorse the authors' plea that these regulations, and their national implementation, are harming the very group they were designed to protect, and should be amended as a matter of urgency.