EU to propose rules to boost clinical trials

The European Commission is expected to soon propose new rules designed to make it easier for drugmakers and researchers to carry out cross-border clinical trials. According to the agency, the number of clinical trials carried out in the EU has fallen by 15 percent in recent years, a decline that researchers attribute to higher administrative costs and the implementation of rules in 2001 designed to increase patient safety.

Under the proposed rules, which are slated to be announced July 17, companies or researchers seeking to hold clinical trials in more than one EU member state could use a harmonised EU submission system, as opposed to filing separate applications in each country where the trial is being conducted. About a quarter of all EU trials currently involves between three and five countries, according to the Commission.

In addition, the Commission is expected to replace the current EU directive under which each member state must transpose into its own national law, with an EU regulation applying equally in all 27 countries. Once published, the Commission's proposal will have to be jointly agreed by EU governments and the European Parliament, which could take up to two years.

German MEP Peter Liese said the proposals aim to fix mistakes in the original directive that hampered trials in Europe and pushed them into poorer countries, such as India. "It's a delicate balance, but we think we have a responsibility there for the poor people that risk their life in India, but also for the patient in Europe that might not be treated in the optimal way when the data are not generated under reliable conditions," he noted. Liese also proposed that the new law include the possibility for member states to "opt out" of multinational clinical trials and called for the "proper" registration of all clinical trials inside and outside Europe. Finally, the MEP suggested different rules for trials carried out by academics, charities or patient organisations, allowing them to start faster and operate with less regulation since these trials are considered less risky than commercial trials because they evaluate drugs already on the market.

For further analysis, read ViewPoints: Despite clinical trial proposals, European market remains increasingly complex.

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