12 September 2018 - Following the 2012 EC guideline, sponsors must ensure that all trials registered on EUCTR since 2004 disclose their results to the EMA within 12 months of trial completion; phase I trials are exempt unless they are denoted as being part of a paediatric investigation plan.

Goldacre et al. set out to ascertain compliance rates with the European Commission’s requirement that all trials on the EU Clinical Trials Register post results to the registry within 12 months of completion (final compliance date 21 December 2016); to identify features associated with non-compliance; to rank sponsors by compliance; and to build a tool for live ongoing audit of compliance.

Of 7274 trials where results were due, 49.5% (95% confidence interval 48.4% to 50.7%) reported results.

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