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.

The measure, which came into force in 2004, has been plagued by concerns from the outset. In 2008, the EU promised to re-assess the directive's impact and to make legislative changes “if needed” in 2012.

Ironically—given the directive was meant to standardize the monitoring and regulation of trials across member states—it is being interpreted differently in each country, making multicenter trials virtually impossible, the consortium's statement says.

The eagerness to harmonize processes has led to an ineffectual one-size-fits-all approach that has left researchers drowning in red tape. For instance, all trials are subject to excessively cautious protocols so that trials of well-known drugs are regulated as stringently as those of completely new drugs.

Traditional large-scale clinical trials can also lack the flexibility that modern medicine requires, says Marie-Cécile Le Deley, at the Institut Gustave-Roussy in Villejuif, France. Le Deley, who presented data from simulating different trial designs at the 2011 European Multidisciplinary Cancer Congress in Stockholm in September, found that for rare cancers, which by definition have small numbers of affected individuals, lengthy large-scale trials “may be counter-productive.”

What is needed instead, says Mark Walport, director of the Wellcome Trust, is “regulation that is proportionate to the risks” involved. For example, says Bell, “The UK Medicines and Healthcare products Regulatory Agency has developed guidelines in the UK that are currently being trialed and could be used to inform a proportionate approach in the EU.”

A 2008 study showed that, on average, approvals in Europe took 67 days compared with 15 days in the US for the same global drug trial (Br. J. Clin. Pharmacol. 66, 546–550, 2008). Walport says delays such as these “make Europe less competitive internationally, resulting in industrial and academic groups moving to other countries in the world to undertake their research.”