DAVID GRANOVSKY

UK to set up new clinical trials agency

In STEM CELLS IN THE NEWS on August 6, 2010 at 12:49 pm

We will keep our eyes on this development and see if the change creates an improved clinical trial environment. -dg

UK to set up new clinical trials agency 5 August 2010

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Policy | Life sciences | Clinical trials | United Kingdom

Nuala Moran

The UK government is to set up a single agency to supervise clinical trials, in a bid to cut through the bureaucracy that has led to a flight of academic clinical research from the country.

The formation of the new agency is proposed at the same time as the axe is taken to quangos and other arms-length agencies across all other areas of government. This includes plans to close 15 agencies that support the National Health Service (NHS), leaving only three existing agencies intact. The new clinical trials body will be in addition to these three.

Health bodies facing the chop include the Human Tissue Authority, which oversees the European Union Advanced Tissue Products legislation and the Human Fertilisation and Embryology Authority, which is responsible amongst other things for awarding licenses for human cloning for embryonic stem cell research.

The proposed clinical trials agency is presented as the route around the red tape that has engulfed clinical research since the coming into force in April 2004 of the EU Clinical Trials Directive. This was intended to harmonise clinical trials activity across Europe, but is widely acknowledged to have had the opposite effect, with different member states implementing its requirements more, or less, stringently.

UK participation in global clinical trials dropped from 6 per cent in 2002, to 2 per cent in 2006…

via Science|Business UK to set up new clinical trials agency.

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