Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what lessons the Government has learnt from the ability to rapidly approve covid-19 clinical trials; and how the Government plans to implement that learning to expedite the approval process for all clinical trials.

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 Health Research Authority (HRA) instigated procedures for rapid advice, reviews and approvals for COVID-19 trials, prioritising these and authorising them in about one week.

As of 2 July, 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 produced guidance on regulatory flexibilities available to clinical trial sponsors and proportionate approaches so that trials could be run as efficiently as possible.

In collaboration with trial sponsors and partners across the healthcare system a ‘lessons learned’ exercise will determine which initiatives in the emergency situation would be appropriate and sustainable in the ‘business as usual’ situation.