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 May 2022, edition 2)‘ document over the What’s New Section on June 27, 2022:
KPIs to monitor the European clinical trials environment: It is the second report posted for the period May 01, 2022, to May 31, 2022, consisting 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)). The data is divided into sponsor type, mono-national or multi-national, clinical trial phase, and therapeutic area. A cumulative data from January 31, 2022, is also available for all the below parameters:
- Clinical trials submitted under the Clinical Trials Regulation (CTR)
- Clinical Trial Applications submitted under the Clinical Trials Directive (CTD)
- Ongoing clinical trials in CTR and CTD
- Clinical trials with a decision issued with/without deferrals under CTR and CTD
- Submitted, validated, authorized, rejected, lapsed, and withdrawn Substantial Modification (SM) applications
- Average time from submission to reporting date, and to first decision for initial applications and Substantial Modifications (Part I or Part I and II): It provides a calculated average number of days required to get a decision on the submitted initial clinical trial application (CTAs) using the dates of 8 authorized initial CTAs.