Under Half Of CTIS Trials Met Results Reporting Requirements

According to a new study, Assessing Compliance with Reporting Requirements in European Phase II–IV Clinical Trials (preprint, not yet peer-reviewed), fewer than half of European Phase II–IV drug trials legally required to post results fully complied on time.

This first assessment of CTIS compliance noted that noncompliant elements included no scientific summary uploaded at all; a scientific summary uploaded but missing basic content (no participant numbers, no outcome data for primary endpoints, or results described as still being analyzed); data simply redacted; and a scientific summary present but no layperson summary.

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.