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Coronavirus: Clinical Trials

Question for Department of Health and Social Care

UIN HL6354, tabled on 1 July 2020

To ask Her Majesty's Government what lessons they have learned from the rapid operation of COVID-19 clinical trials; and what plans they have to use that learning after the COVID-19 pandemic to speed up the approval process for all clinical trials.

Answered on

17 July 2020

The response to the COVID-19 pandemic has shown that the United Kingdom healthcare research and approvals system has the agility and flexibility to respond efficiently to a national crisis. The Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) instigated procedures for rapid scientific advice, reviews and approvals for COVID-19 trials, prioritising these and authorising them in about one week.

As of 2 July, the MHRA has authorised a total of 61 trials for the treatment or prevention of COVID-19 in an average of nine days. A total of 50 trials for the treatment or prevention of COVID-19 have been approved by both the MHRA and the HRA in an average of 12 days. Both the MHRA and the HRA have also produced guidance on regulatory flexibilities available to clinical trial sponsors and proportionate approaches so that trials could be run as efficiently as possible.