European trial coordinators ‘facing risk of US fines’

Transparency organisation alleges several institutions have not followed US reporting rules

European research institutions are putting themselves at risk of massive fines from the United States for not reporting clinical trial results, an organisation that campaigns for trial transparency has alleged.

There has been a major focus in Europe on ensuring that the results of clinical trials are made public after the research is complete, and this is now enshrined in EU law. But there has been less attention paid to the fact that European clinical trials may also need to comply with US disclosure rules.