Update 30.03.2020 | The European Commission, the European Medicines Agency (EMA) and national Heads of Medicines Agencies (HMA) have published new recommendations on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic. The impact of the pandemic on European health systems and more broadly on society will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials.
The “GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC” 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.
The guidance was agreed by the Clinical Trials Expert Group (CTEG) of the European Commission, supported by EMA, the Clinical Trials Facilitation and Coordination Group (CTFG) of HMA and the GCP Inspectors’ Working Group. It provides a harmonised approach in the conduct of trials, to mitigate the negative effects of the pandemic.
The release of the guidance has been announced by an EMA press release. - https://www.ema.europa.eu/en/news/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic
Both the US and European regulatory authorities have issued their respective guidance to ensure continued patient safety and continued data quality during the COVID-19 crisis.
