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 ...
