COVID-19 emergency – what actions have been implemented in the European context
Guidance on the Management of Clinical Trials during the COVID-19 pandemic
EU authorities recently published the Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic, a recommendation to guide sponsors on how to manage clinical trials and their participants, given the impact of the COVID-19 pandemic on European health systems.
The guidance provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations, e.g. if trial participants need to be in self-isolation or quarantine, access to public places (including hospitals) is limited due to the risk of spreading infections, and healthcare professionals are being reallocated. There is specific advice on the initiation of new clinical trials for treatments of COVID-19, and in particular on the need for large, multinational trial protocols.
Please check EMA’s website for further updates: https://www.ema.europa.eu/en and consult also instructions regarding clinical trials issued at national level and provided by the national authorities (e.g. Medicines Agencies) and hospitals.