The European Medicines Agency (EMA) has called for a pooling of EU research resources into large-scale, multi-centre, multi-arm clinical trials against COVID-19.
With the number of people hospitalised and requiring treatment increases daily, a harmonised and robust methodology for data collection is necessary.
The Committee for Medicinal Products for Human Use (CHMP) is aware that several hospitals and academic institutions plan to start investigational studies locally. CHMP considers that it is critical to generate randomised controlled trials, to generate data that could lead to timely regulatory decisions and promptly guide clinicians to best treatment regimens against COVID-19. They are concerned that many small studies are unlikely to generate the required level of evidence to allow clear-cut recommendations.
Multi-arm clinical trials, with simultaneous agents, have been developed for COVID-19 by institutions in the EU and by the WHO. It is important that all EU countries are considered for inclusion in these trials.
These studies should also include paediatric populations, of adequate size to inform on safety and pharmacokinetics in this cohort.
The EMA strongly recommend that a coordinated approach across the EU is pursued, to prioritise larger multi-country randomised controlled trials that have the potential to generate confirmatory evidence.