Key performance indicators (KPIs) to monitor the  European clinical trials environment Metrics on the Clinical Trials Regulation and Clinical Trials Directive


On the 31 January 2022 the Clinical Trials Regulation (EU) No 536/2014, hereinafter ‘CTR’, repealing the Clinical Trials Directive 2001/20/EC, hereinafter ‘CTD’, became applicable and the Clinical Trial Information System (CTIS) was launched. In line with the provisions outlined in Article 97 of the Clinical Trials Regulation, the European Commission shall assess the impact of the Regulation on scientific and technological progress.

This report provides an overview of Key Performance Indicators (KPIs) related to the implementation of the CTR. The Clinical Trials Regulation Metrics report is published on a monthly basis starting in May 2022. The previous report can be found at this link.
This report is published as part of the business change programme Accelerating Clinical Trials EU (ACT EU), involving the European Commission, the Heads of Medicines Agencies (HMA), Clinical Trial Coordination Group (CTCG) and the Agency.
ACT EU seeks to transform how clinical trials are initiated, designed and run. One of the priority actions of ACT EU focusses on monitoring the implementation of the CTR.

The metrics presented in the report reflect the status of applications in CTIS and EudraCT1 as of 31 October 2022 for Clinical Trial applications (CTA) submitted between 1-31 October 20222 as well as cumulative figures.