EMEA MOVES TO BOOST CONTROLS OF NON-EU CLINICAL TRIALS

BY KEITH NUTHALL

INCREASED controls on clinical trials staged outside the European Union (EU) and north America are planned by the European Medicines Agency (EMEA). The EU agency has released a report noting the "growing concern both among regulators and in public debate about how well these trials are conducted from an ethical and scientific/organisational standpoint...and the supervision of these trials." It noted that around 25% of patients used in "pivotal trials submitted between 2005 and 2008" were recruited in Latin ...


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