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European Move Affects Academic Trials Research
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Imagine trying to conduct a clinical trial across several countries, each with its own set of rules. One country would require that all sponsors formally apply to a central ethics committee, whereas another would merely ask for a letter notifying their ethics committee of the trial. One country would respond within 3 weeks, another within 5. The inconsistencies among countries would delay the trial, create extra paperwork, and demand an army of professionals to navigate the legal and bureaucratic landscape.
That was the situation for anyone wishing to conduct multinational clinical trials within Europe before the European Union. In 2004, the European Union issued a clinical-trials directive to harmonize clinical trials research across its 25 member countries and better protect trial participants. Rather than fixing the problem, though, recent efforts have made things worse, according to some trial sponsors.
Several academic researchers, including those conducting cancer studies, have had to
Cancer Hit Hardest
Fixing The Problem