Expert Scientific Group: Phase 1 clinical trials

31 July 2006

The Royal Society recently responded to the Expert Scientific Group study on phase I clinical trials which was established by the Secretary of State for Health following the severe adverse events experienced by some of the volunteers taking part in the trial of the anti-CD28 antibody TGN1412.

Our response focused on the steps that need to be taken to optimise the safety of phase I clinical trials involving very novel biological molecules, new agents with a highly species-specific action and new drugs targeted towards the immune system. These groups of drugs offer great potential, but due to the limited previous experience of the development of such drugs, exceptional care must be taken in designing phase I clinical trials, particularly with with regard to the initial dosing and the time intervals between doses of a drug in an individual and between individuals.