Europe proposes reform to clinical trial regulations

27 July 2012

The European Commission has formally adopted proposals to revise its Clinical Trials Directive.

The new rules are intended to halt a recent steady decline in the number of clinical trials taking place in Europe by reducing the amount of red tape required to carry them out; applications to conduct clinical trials within the EU fell by around 25% in the four year period to 2011. Current procedures have been criticised by researchers, drug companies and patient groups for being both prohibitively bureaucratic and inconsistently applied across nations.

The proposed reforms include a simplified application process for trials that are to run in more than one country via submission to a central electronic portal, and less onerous insurance and reporting obligations for lower risk trials such as those using already-approved drugs or involving minor modifications to current clinical treatments. Scientific assessment of trials will be coordinated centrally under the new proposals, but ethical assessment will continue to be carried out on a national basis.

The Commission estimates that the current directive, introduced in 2001, has led to a doubling of the costs and labour associated with authorising new trials in Europe and has put the EU at a disadvantage in comparison with other parts of the world, particularly Asia, Russia and South America. It wants the reforms to be passed as a regulation rather than a directive, to ensure compliance and enforcement across the EU (directives are not compulsory). To become law the adopted proposals will need to be passed by the European Parliament and Council of Ministers.

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