Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
European Medicines Agency
We hope you are well and we wish you all the best in these challenging times.
We would like to bring to your attention that EU authorities have published today recommendations to guide sponsors on how to manage clinical trials and the people who participate in these trials, given the impact of the COVID-19 pandemic on European health systems: Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic . 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.
This crisis will likely also have an effect on Enpr-EMA activities this year. We will keep you informed as soon as possible and in coordination with the Agency’s COVID-19 Business Continuity Planning.
All the best to you and your families, and for your important work in health care!
Kind Regards, on behalf of:
Chairs of the Enpr-EMA Coordinating Group
Pirkko Lepola and Gunter Egger