Getting Efficacy into European Trials

Europe remains as challenging as ever for clinical trials, but also for everyone trying to make sense of Europe as a political entity. The jumbo meeting on clinical trials at the European Medicines Agency in early October—on which a report appears at http://www.actmagazine.com|~www.actmagazine.com/appliedclinicaltrials/Clinical+Trials/Composite-Endpoints-Proceed-with-Caution/ArticleStandard/Article/detail/463968—provided further evidence of just how complex life can become in the European Union. This unique organization binds 27 member states together tightly, voluntarily, legally—but not completely. And the conduct of clinical trials is one of the activities that keeps slipping between the gaps in the curious configuration of EU rules, which resemble wickerwork more than cast-iron.

This is not the place for a lengthy disquisition on the constitution of the EU. Suffice it to say that the 27 member states not only disagree with one another on clinical trials regulation, but that even where they do agree in principle, they frequently disregard at national level the rules they have created at the European level.

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