Changes to COREC Application for Phase 1 Trials

The application process for Phase 1 trials has been amended in response to the MHRA's adoption of a 'precautionary approach' for studies of this kind

As a result of the interim findings into the adverse incidents in the TGN1412 trial at Northwick Park, the MHRA announced it will take a 'precautionary approach' to all further clinical trial applications (CTA) involving:

• First-in-man trials of any monoclonal antibody (regardless of intended target) or
• Other novel molecules targeting the immune system, acting via a novel mechanism.

Such trials will not be authorised without having had additional expert opinion on whether the effects seen in the TGN1412 case may be repeated in relation to those substances. The Commission on Human Medicine (CHM) will carry out a preliminary review of the proposed trial prior to authorisation, taking into account the expert advice. The MHRA Clinical Trials Unit will provide a response to the Sponsor/Chief Investigator following review by the CHM.

Consequently, COREC have amended their application process in line with this 'precautionary approach'.

Now, when question 2 (Is your study a clinical trial of an investigational medicinal product?), is answered 'yes' an additional question should appear: Is this a Phase 1 trial under precautionary measures from the MHRA? Yes/No

If the application falls into this category, the application for ethical review should ALSO include:

• A covering letter explaining what discussion has taken place with the MHRA
• How the protocol has been revised in line with advice from CHM (if applicable)
• A copy of any correspondence with the MHRA

If such discussion has not yet taken place, or is still underway, the applicant is requested NOT to submit the application for ethical review yet.