The study found that fewer than half of European Phase II–IV drug trials legally required to post results fully complied on time.
A new study finds fewer than half of EU Clinical Trial Information System (CTIS) trials met results reporting requirements. The European Medicines Agency (EMA) is now watching more closely. So are advocacy groups and journalists. Here is what sponsors need to know.
A new study, Assessing Compliance with Reporting Requirements in European Phase II–IV Clinical Trials (preprint, not yet peer reviewed), the first assessment of compliance on CTIS, found that fewer than half of European Phase II–IV drug trials legally required to post results fully complied on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 paying attention to.
Noncompliance took more than one form:
Both the scientific summary of results and the layperson summary are required under Article 37 of the Clinical Trials Regulation (CTR), and a submission is only compliant when both are present and complete. The full content requirements for each are defined in Annex IV and Annex V of the CTR and detailed in the Sponsor Handbook.
Worth noting: The study assessed only two of the 24 legally required items to categorize a trial as compliant, specifically whether the document stated the number of participants enrolled and whether it contained outcome data for all primary endpoints. The authors acknowledge this means the compliance rate is likely overstated. There is no prescribed template or structured format beyond what Annex IV and V define, and CTIS has no system-level content check. The first version of a results document uploaded to CTIS is the public-facing version, which means content quality rests entirely with the sponsor. The gap between what is being submitted and what the law requires may be wider than it appears.
The document quality finding is relevant to all sponsors. Regulators, advocacy groups, and journalists are no longer looking only at whether something was uploaded. They are looking at what is inside. A submission with missing or inadequate content is not compliant, and it is now more likely to be identified as such. The study could not assess differences in compliance by sponsor type given the size of the cohort, so no sponsor category should assume the problem sits elsewhere.
According to the EMA, enhanced monitoring capabilities are now in place allowing national competent authorities to track which trials in their territory are overdue. Advocacy groups and journalists are actively reviewing submissions and contacting noncompliant sponsors by name. A public compliance dashboard is explicitly on the advocacy agenda. The question of consequences, including public naming and the use of existing enforcement powers held by national competent authorities, is on the table.
The EMA moved quickly after 20 health and patient advocacy groups wrote to its management board in June. Actions already underway:
Two measures remain outstanding: a public compliance dashboard naming sponsors and their submission rates, and a formal quality assurance system for submitted results. Both are actively being pushed by advocacy groups.
No sanctions have been imposed on sponsors to date for failing to report on CTIS. That history should not be read as policy. Sponsors should:
With over 8,400 Phase II–IV trials now registered on CTIS, the volume of results coming due will grow significantly over the next few years. Sponsors that have results reporting well in hand have less to worry about. Those who do not should be moving now.
Managing CTIS compliance across a large trial portfolio is operationally complex. Citeline works with many of the world’s leading pharmaceutical companies to track obligations, manage deadlines, and support compliant submissions. Our customers are among the best in the industry when it comes to disclosure compliance. If you are evaluating your CTIS readiness, find out more here and schedule a demo.
