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EU directive on clinical trials will cost lives

The volume of research conducted in Europe will be driven down dramatically and thousands of lives will be lost if a directive developed by the EU becomes law next year, warned leading UK research directors last week.

Zosia Kmietowicz

LONDON. The volume of research conducted in Europe will be driven down dramatically, and thousands of lives will be lost, if a directive developed by the EU becomes law next year, warned leading UK research directors last week.

The guidance, which demands extra data collection, form-filling and inspections for even the most basic clinical trial, is diametrically opposed to what experts have been calling for - more simple and user-friendly trials.

The EU has made a "lethal error", said British Heart Foundation Professor of medicine and epidemiology at the University of Oxford, Rory Collins. "Bureaucrats who wouldn't know a clinical trial if it bit them have taken guidelines from the International Conference on Harmonisation (ICH) and bastardised them. If it becomes law it will have a most destructive effect on research and will mean that many people in Europe will die unnecessarily because it will be an obstacle to finding...

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