Nature Medicine | Spoonful of Medicine

Research organizations push back against clinical trials directive

By Priya Shetty

LONDON — European legislation intended to streamline clinical research is so steeped in bureaucracy that it is threatening “the development of potentially lifesaving treatments,” says a consortium of 16 research organizations, including Cancer Research UK, the Wellcome Trust and the UK’s Academy of Medical Sciences.

In late September, the consortium issued a statement calling on the EU to include changes that would cut red tape and streamline the authorization of clinical trials as part of its planned revision to its European Clinical Trials Directive (ECTD) in early 2012.

Instead of smoothing the process, “the directive has increased the administrative burden and cost of clinical trials, with no evidence of discernible benefits to patient safety or to the ethical soundness of trials,” John Bell, president of the Academy of Medical Sciences, told Nature Medicine.

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