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Scrip Regulatory Affairs
EU Clinical Trial Rules Look Ready for Change
06 August 2009
Ian Schofield

Criticism of the European Union’s 2001 Clinical Trials Directive is nothing new. Concerns about its adverse effects on clinical research, both commercial and academic, have been voiced pretty much since its provisions came into effect in 2004.

Sponsors of noncommercial studies, such as the European Organisation for Research and Treatment of Cancer and the Irish Clinical Oncology Research Group, have been particularly vocal...

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