EU Will Measure Results Reporting, But Who Verifies The Content?

The Accelerating Clinical Trials in the EU (ACT EU) quarterly performance reports will add a results-reporting metric, with the first expected before the end of the year. In July, the European Medicines Agency (EMA) told advocacy groups the reports would include the number of trials in the Clinical Trials Information System (CTIS) with available results summaries. The EMA currently describes a percentage of trials that comply with the requirements, with that number coming in at around 87%.

The EMA also said that simply uploading a document does not demonstrate that its content meets the requirements, and that the network will consider actions to verify completeness and quality. However, none of the EMA statements indicate who will check the content of results documents or when, which could leave this task undone.