CCRA welcomes the interim findings of the MHRA on the conduct of a Phase I study at Northwick Park Hospital with TGN1412.

Clinical studies in the UK are tightly regulated and our member Phase I units have their own operating procedures to ensure that the highest standards of supervision and diligence are met.

We are pleased to learn that 5 of the volunteers are sufficiently well to have been discharged from hospital. Our thoughts remain with the person still in hospital and his friends and family. We wish him a speedy and full recovery. 

Biotherapeutic entities clearly need to be considered further especially when they may affect the immune system in healthy volunteers. It would not be useful for us to speculate on what should be done differently in the future but we will work closely with the relevant experts to ensure that the UK remains at the leading edge of excellence and safety in clinical trials.