Interim report on Phase I Clinical Trials

The interim report of the expert group brought together to examine the design of phase 1 clinical studies is now available.

The Expert Scientific Group (ESG) was convened by the Secretary of State for Health to look at how to improve the safety of drug trials involving products such as monoclonal antibodies, following adverse reactions experienced by participants in the clinical trial of the drug known as TGN1412 earlier this year.

The recommendations include:

• in drug trials of this type the first dose should be given to one person only, leaving sufficient time for any adverse reaction to develop before further doses or administration to more people
• in some circumstances and particularly if the drug is to affect the immune system, first studies may more appropriately involve patients being treated for the disease rather than healthy volunteers
• earlier dialogue between the drug developer and regulator in the case of higher risk agents to allow thorough review of safety data
• better international sharing of information about serious adverse reactions to drugs in trials, and
• the development of specialist centres to undertake phase one studies on higher risk agents.

The recommendations are now out for consultation before a full report is published later this year.