European guidelines for the management of clinical trials during the coronavirus pandemic are available.
The European guidelines are the result of collaboration between the European Medicines Agency (EMA), the Good Clinical Practice Inspectors Working Group, the Heads of Medicines Agencies (HMA), the Clinical Trials Facilitation and Coordination Group, the European Commission, the Clinical Trials Expert Group, and national competent authorities such as the FAMHP (together with the Clinical Trial College and the Ethics Committees).
These new guidelines should assist clinical trial sponsors in the management of clinical trials:
- clinical trials for the prevention or treatment of COVID-19;
- ongoing clinical trials in Belgium;
- advice for new unrelated COVID-19 clinical trials.
For a number of specific issues the FAMHP will develop detailed national guidelines such as direct delivery to patients.
These national guidelines will be published on 25 March 2020.