The clock is ticking for the implementation of a common set of rules that will regulate the conduct of clinical trials in EU member states. The European Commission (EC) passed the EU directive on clinical trials in May 2001 in an attempt to simplify the clinical testing of medicines in Europe and to ensure that trials meet the highest standards of quality. Member states must comply with the new rules by May 1, 2004. But, some scientists worry that the proposed regulations will damage noncommercial clinical research.
The rules were originally designed with licensing trials in mind. The EC extended them to cover not only commercially funded trials, but also those sponsored by government, charities, or academic institutions. As a result, even the most basic clinical trials will be required to comply with standards of good clinical practice, and in most cases, this means extra paperwork, inspections, and extensive data...
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