August 2022: Key Performance Indicators to Monitor European Clinical Trial Environment

European Medicines Agency updated the page, Clinical Trials Regulation: progress on implementation by adding ‘Key performance indicators (KPIs) to monitor the European clinical trials environment (1 – 31 July 2022, edition 4)‘ document over the What’s New Section on August 23, 2022:

This fourth report posted for the period July 01, 2022, to July 31, 2022, consists of the metrics for the submitted and authorized clinical trial applications along with the non-authorized clinical trials. The data is reported from the two EU clinical-trial databases (Clinical Trials Information System (CTIS)  and European Union Drug Regulating Authorities Clinical Trials (EudraCT)) and it is divided into sponsor type, mono-national or multi-national, clinical trial phase, and therapeutic area. Refer to the previous post for the details on the parameters for which the cumulative data is presented in the KPIs.

This report also includes the Annex I section where the average time from the submission of the initial clinical trial up to the time of the first decision of the Member States Concerned is enlisted.