Trial suspended as 6 admitted to intensive care

The Medicines and Healthcare products Regulatory Agency (MHRA) has said that it has suspended a clinical trial for a drug following some of the subjects involved being admitted into intensive care.

MHRA said that the phase I trial was for a new product in development to treat chronic inflammatory conditions and leukaemia, but that the trial was suspended when six of the eight men involved in the trial were admitted to intensive care.

The two men not admitted formed the placebo group, meaning 100 per cent of those who were administered with the medication were admitted.

“Our immediate priority has been to ensure that no further patients are harmed,” said Professor Kent Woods, chief executive officer at MHRA.

“We will now undertake an exhaustive investigation to determine the cause and determine all appropriate actions are taken.”

The MHRA will now be sending inspectors to an independent medical research unit to start investigations. It is also working with the Department of Health, Metropolitan Police and the North West London Strategic Health Authority.

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