January 2023: Key Performance Indicators to Monitor European Clinical Trial Environment

On January 31, 2023, 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 December 2022, edition 9‘ document over the What’s New Section.

It is the ninth report posted for the period December 1, 2022, to December 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:

  1. Clinical trials submitted under the Clinical Trials Regulation (CTR).
  2. Clinical Trial Applications submitted under the Clinical Trials Directive (CTD).
  3. Ongoing clinical trials in CTR and CTD.
  4. Clinical trials with a decision issued with/without deferrals under CTR and CTD.
  5. Submitted, validated, authorized, rejected, lapsed, and withdrawn Substantial Modification (SM) applications.
  6. 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.

Annex I include the average time from the submission of the initial clinical trial up to the time of the first decision of the Member States Concerned.