[Correspondence] Centralised ethics review of clinical trials in a public health emergency in the EU

The COVID-19 pandemic caused major excess mortality worldwide. Although many innovations originated in the EU, pivotal vaccine, diagnostic, and therapeutic trials largely occurred outside the EU. Unlike the more centralised approaches in the USA and UK, the EU's fragmented clinical trial system—particularly the complex trial application (CTA) and approval processes across 27 member states and European Economic Area countries—slowed research response.