science

UK Medicines Watchdog Suspends Clinical Trial Authorisation

The Medicines and Healthcare products Regulatory Agency (MHRA) has today suspended a phase 1 clinical trial for a new product that is being developed to treat chronic inflammatory conditions and leukaemia, having been notified that six men involved in the first stages of a clinical trial have been admitted into intensive care.

Eight men took part in this stage of the clinical trial; six were given the product and two were given a placebo. The MHRA has been assured by those running the trial that nobody else has been given the product. The MHRA has also notified other European regulatory bodies.

The MHRA will be sending inspectors to an independent medical research unit on the Northwick Park hospital campus, to start investigations. The MHRA is working with North West London Strategic Health Authority, Department of Health and Metropolitan Police.

Professor Kent Woods, Chief Executive Officer at MHRA said, “Our immediate priority has been to ensure that no further patients are harmed. We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken.”