European drug agency under fire: critics charge that trial data are too inaccessible.

摘要

The European Medicines Agency (EMA), the European counterpart to the US Food and Drug Administration (FDA), has lately experienced a number of blows to its reputation, coming under fire over policies related to the accessibility of unpublished clinical trial data in its database, as well as conflicts of interest for its officials. The controversy underscores long-standing concerns that the inaccessibility of unpublished data from clinical trials sponsored by pharmaceutical companies undermines appropriate evaluation of the relative benefits and risks of a medication.