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New EU Protocol Aims to Improve Clinical Trial Transparency

A new regulation and registry covering investigational medicinal products mandates reporting and supports multinational trials.

Written bySophie Fessl, PhD
| 4 min read
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According to the EU Trials Tracker, one-fifth of clinical trials run in the European Union do not report their results, with not even a brief summary of their findings posted in a register. This means negative results are not always made public, potentially distorting evaluations of an intervention’s efficacy and slowing medical research. It’s a problem that the Council of the European Union and the European Parliament aimed to solve in 2014 when they adopted the Clinical Trials Regulation (CTR)—a new set of rules governing clinical trial applications. Now, as of January 31, the CTR is finally in effect, and researchers are hopeful it will live up to its goal of improving transparency.

One of the key stipulations of the CTR is that it mandates reporting of study results within a year of a trial’s conclusion. The Regulation also aims to foster large, multinational collaborations by allowing applications for investigational ...

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