Revised guidance relating to Clinical Trials during the COVID-19 Pandemic
During the ongoing pandemic pragmatic and harmonized approaches are needed to ensure flexibility and procedural simplifications required to maintain the integrity of clinical trials and to ensure the rights, safety and wellbeing of trial participants and the protection of clinical trial staff. Due to this, the Guidance on the management of clinical trials during the COVID-19 Pandemic has been updated (version 5) and published on 10th of February 2022. The key changes compared to version 4 from February 2021 are relating to updates with references to the EU Clinical Trials Regulation (CTR) No. 536/2014 which entered into application on 31 January 2022.
The points mentioned in the guidance are intended to provide clarity for all parties involved in clinical trials during the COVID-19 Pandemic. However, it should be noted that the simplifications proposed will only last until the revocation of the Guidance.
The current version considers that clinical trials can be authorized during the transition period both under the Clinical Trials Directive (2001/20/EC) and the CTR. Regulatory flexibilities provided in the guidance linked with additional risk adaptations are therefore applicable also for clinical trials that have been authorized under the CTR. Sponsors and investigators should note that due to the rapidly evolving situation further updates to the guidance might be possible and likely.