European bureaucracy is making it more difficult to run large clinical trials for new oncology drugs, according to the latest Cancer Research UK report published in the European Journal of Cancer.
The European Union Clinical Trials Directive was intended to harmonise standards across the continent, making it easier for international groups to collaborate, the report states, but because every member state implements European laws in a slightly different way, the effect has actually been to increase costs, delay the start of trials 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, the study claims.
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.
He added that “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.
Dr Sullivan concluded by saying that “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.”
