In the EU, clinical trials are authorised and supervised at national level. In order to complement the EU Guidance on the Management of Clinical Trials during the Covid-19 coronavirus pandemic, the Belgian government issued its own Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic. The Belgian guidance is the result of collaboration between the FAMHP, the Clinical Trial College, the Belgian Association of Research Ethics Committees (BAREC) and a number of Belgian research centres. It provides more details for clinical trial sponsors in the management of clinical trials for the prevention or treatment of Covid-19 and other ongoing clinical trials in Belgium. In particular, it includes:
- Guidance on “procedure and communication with authorities”. Sponsors are invited to consider the accelerated Voluntary Harmonisation Procedure when submitting a multi-country Covid-19-related trial.
- Rules on “restrictions of visits to healthcare facilities” and how to deal with particular cases (for example, if a Belgian patient is enrolled in a trial in another member state and the foreign site closes due to the Covid-19 situation). “The principal investigator and the sponsor are invited to obtain a solution in the best interest of the participating patient.”
- Guidance on “shipment from the site to the patient”. Direct shipment from sponsor to patient is generally not allowed in Belgium but is being temporarily permitted due to the exceptional nature of the pandemic.
- Explanation of the notification duty of “temporary halts and urgent safety measures (USMs)”. A temporary halt of the trial (for example, recruitment halt, halt of the trial on a site) shall be submitted to the FAMHP and the European Commission within 15 days of the decision.
- Electronic ways of working and accepting electronic signatures. In addition to the rules set out in the EU guidance document, the Belgian guidance provides practical information on how to deal with electronic ways of working (for example, in relation to cover letters, application forms and protocols, a scan or photograph of the signed hardcopy will be accepted).
This guidance will be regularly updated as the Covid-19 pandemic evolves.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2020 Issue (Thomson Reuters)