Call To Pool Research Resources into Large Trials to Generate Evidence On COVID-19 Treatments

EMA’s Human Medicines Committee (CHMP) has published a statement urging the EU research community to prioritize large randomized controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of COVID-19. The statement promotes a harmonized approach to data collection and a robust methodology for COVID-19 clinical trials across the EU to make best use of the available supply of investigational agents. It emphasizes the need to include all EU countries in these trials.

At the moment, there are no approved medicines to protect from or treat COVID-19. The CHMP has discussed the ongoing outbreak and emphasizes the critical need for robust data to determine which investigational or repurposed medicinal products would be safe and effective for the treatment of COVID-19. The Committee is concerned that clinical trials with a small number of participants or compassionate use programs might not generate the data required to draw firm conclusions on the effects of a given therapeutic and give appropriate advice to healthcare professionals and patients.

The Agency is currently engaging with different stakeholders that can further support the conduct of COVID-19 clinical trials across Europe.