CTIS Results In The Spotlight

A new study, the first assessment of compliance on the EU Clinical Trial Information System (CTIS), finds fewer than half of CTIS trials met results reporting requirements. The European Medicines Agency (EMA) is now watching more closely. So are advocacy groups and journalists. Disclosure expert Francine Lane, Head of Transparency at Citeline, shares what sponsors need to know.

The study, Assessing Compliance with Reporting Requirements in European Phase II–IV Clinical Trials (preprint, not yet peer reviewed), found that fewer than half of European Phase II–IV drug trials legally required to post results fully complied on time. The research team includes contributors to both the FDAAA Trials Tracker and the EU Trials Tracker; lead author Till Bruckner has worked in clinical trial transparency and disclosure for years. This is a group worth watching.