EMA calls for large-scale RCTs and harmonised data collection for COVID-19

19 March, 2020

The European Medicine Agency’s (EMA) Human Medicines Committee is urging the EU research community to prioritise randomised controlled studies and to use a harmonised approach for data collection, in order to enable the rapid development of potential treatments for COVID-19.

In the statement, published today (19 March, 2020), the EMA emphasises the need to include all EU countries in these trials, and highlights the importance of robust methodologies for COVID-19 clinical trials that make best use of available investigational agents.

The statement warns against clinical trials with small numbers of participants, as the Committee says small studies may not be able to generate sufficient data on the effects of therapeutics.

The EMA says it is ready to support medicine developers to advance and expedite measures to treat or reduce the spread of COVID-19. It advises those who are involved in the development of potential therapeutics or vaccines against COVID-19 to contact the EMA with information about their proposed development: 2019-ncov@ema.europa.eu