European Parliament Votes In Favor Of Transparent Clinical Trials

The European Parliament voted in favor of new legislation that would change the way clinical trials are run in the European Union. The goal of the new legislation is to make it easier to get clinical trials started in the EU, as well as making the process and results of clinical trials — even the negative ones — more transparent. This new legislation is expected to take effect in 2016 and will result in the publication of all results from new clinical trials.

In the legislation's Explanatory Statement, legislators stated that the number of clinical trials performed in the EU dropped 25 percent from 2007 to 2011, and many trials moved to other nations As the statement says, the decreasing number of trials being carried out is a serious problem, not only economically, but also for the advance of medicine for European patients. Legislators worked to reduce the lengths of approval times and bureaucracy in the current process for clinical trial approval. Doctors in the EU had complained that the lack of information available to them from clinical studies made it difficult to know if the drugs that they were prescribing their patients would be effective. The new rules will allow independent researchers to verify the results of clinical studies and learn whether drugs produced by pharmaceutical companies were as safe and effective as the companies claimed.

Ben Goldacre, a British doctor who runs the AllTrials campaign, which was created in January of 2013 to pressure pharmaceutical companies and EU legislators to make clinical trials more transparent. Goldacre called the new legislation 'a small step forward' but he was concerned about the fact that this new legislation only favors new clinical trials, and does not affect medicines examined in past clinical trials.