The 2004 European Union Clinical Trials Directive (2004/23/EC) was thought to harmonise standards across the EU, hence cutting red tape for international groups to work together.
Unfortunately, the report shows that the directive is implemented slightly differently in each Member States, which implies that red tape is not cut, and costs are increased.
Cancer Research UK argues that « 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. »
They therefore call for a revision of the Directive.
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