FOI release

Freedom of Information request on the impact of the COVID-19 pandemic on clinical trials (FOI 22/561)

Published 14 June 2022

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FOI 22/561

14th April 2022

Dear

Thank you for your email request of 17th March 2022 which has been considered under the Freedom of Information Act (FOI Act).

You requested the following information:

  • The number of trials halted or paused during the pandemic and how many of these have since restarted.

  • Any facts and figures on the number of new trials that may be delayed in starting up.

We do not hold all of the information you have requested. We would advise that you contact the National Institute for Health Research (NIHR) who hold data on the status of the NHS research portfolio and are managing the recovery of research impacted by the pandemic. https://www.nihr.ac.uk/

In March 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on how investigators and sponsors should manage clinical trials during COVID-19.  This included pragmatic guidance on managing ongoing and halted trials. https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19#managing-ongoing-and-halted-trials .The following provides some further background information on requirements for informing MHRA of a temporary halt during the pandemic.

During the COVID-19 outbreak MHRA guidance requires trial sponsors to notify the MHRA of a temporary halt to a clinical trial when it involves a direct participant safety issue or a medicines supply issue. MHRA guidance states that if a trial has been halted due to issues related to COVID-19, the sponsor will not normally need to inform the regulator. The trial master file should include a note that the trial was halted and the reason. If a halt is due to either of the below scenarios however, sponsors do need to inform MHRA:

  • A direct participant safety issue, especially if there is the potential to impact other trials;

  • A medicines supply issue (so this can be escalated to DHSC).

Restart of a trial may require changes to the trial conduct, for example to participant monitoring or clinic visits. If the restart of the study does not involve any substantial changes to the Clinical Trial Authorisation (CTA), then a substantial amendment notification to MHRA will not be necessary. If substantial changes do need to be made, for example to protect participant safety or data integrity moving forward then this should be submitted as a substantial amendment in the normal way. If a substantial amendment has been approved to halt the trial, then another to restart will always be necessary.

MHRA does not hold information on the number of trials that may have had delays in starting up after approval was granted as MHRA does not require submission of this information to us. Please also note that MHRA regulates interventional clinical trials of investigational medicinal products.  There may be other research impacted by the pandemic that does not fall under MHRA remit.  Our records show that from 1st February 2020 to 18th March 2022 the MHRA has been notified of 225 temporary halts to interventional clinical trials of investigational medicinal products.

If you have a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

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