2 Steps For Correcting Non-Compliance With EU Disclosure Regulations

By Thomas Wicks, chief strategy officer, TrialScope

European Union (EU) regulations require the disclosure of clinical trial results for all studies within 12 months of study completion or within 6 months for pediatric trials. Over 12,000 studies listed on the European Medicine Agency (EMA) trial register (EU CTR), conducted by biopharmaceutical companies and other industry sponsors, are overdue on results posting. Non-industry sponsors, including academic institutions, hospitals, and public health organization also are responsible for disclosing study information on the EU CTR registry. 

However, nearly 25 percent of these completed trials are missing results.  A further analysis shows that industry sponsors implementing a commercial clinical trial disclosure system have only about 8 percent of their results apparently missing, while sponsors without a disclosure system appear to be missing approximately 42 percent of their results records. While there are a few legitimate reasons why these records are not available, that ratio is high. To address this apparent non-compliance and improve the ratio of completed trials with results, we recommend the following two-step process to take control of your compliance: