European bureaucracy has made running large clinical trials for new cancer drugs more difficult, according to a Cancer Research UK report published in the European Journal of Cancer.
The European U_nion Clinical Trials Directive was intended to harmonise standards across the continent, making it easier for international groups to collaborate. But because every member state implements European laws in a slightly different way, the effect has, in fact, been to increase costs, delay trials starting, and make collaboration more difficult.
Large-scale, multinational trials are the only way to prove the effectiveness of many anticancer drugs, especially those being developed for rare diseases, because of the large numbers of patients needed.
Dr Richard Sullivan, director of clinical programmes at Cancer Research UK and co-author of the report, said: “Our research confirms concerns that the introduction of the 2004 EU Clinical Trials Directive would delay and significantly increase the cost of cancer clinical trials in the UK. Critically, the legislation has also prevented the running of co-ordinated international trials by some trials units due to uncertainty over how each country in the EU is implementing the new rules ? the very situation the Directive was intended to resolve. It is essential to provide proper funding for the academic trials community. A review of how the Directive is being implemented across member states is urgently needed.”