FOI release

Freedom of Information request (FOI 22/820)

Published 17 January 2024

2nd August 2022

FOI 22/820

Dear Enquirer,

Thank you for your request of 11th February where you have asked “We write to request all information pertaining to and or in relation to the HCQ Horby trail including: • Full disclosure of the patient data”

The MHRA does not receive individual patient data from the trial sponsor and, therefore, we don’t have this information to provide. At the end of the trial, the sponsor is required to submit a summary report (and also make this available on a publicly-accessible database) however, this does not include individual patient data. As the RECOVERY trial is still ongoing, an end of trial report has not been submitted to the MHRA at this time. Individual patient data would need to be requested directly from the RECOVERY trial team.

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

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

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

Communications and engagement team

Medicines and Healthcare products Regulatory Agency