Freedom of Information request on clinical study reports from clinical trials on amitriptyline (FOI 21-407)
Published 28 June 2021
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6th May 2021 FOI 21/407
Dear
Thank you for your request, dated 8 April 2021, where you asked for “clinical study reports from clinical trials on amitriptyline submitted to the UK Medicines and Healthcare products Regulatory Agency from the pharmaceutical industry. The trials could be pre-authorization or post-authorization.
We are interested in all randomized controlled clinical trials where amitriptyline was used for major depressive disorders in adult population and compared to placebo, active placebo or no intervention. This also includes trials where tricyclic antidepressants were used as an active comparator.”
As we specified in our previous response, Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information. As your current request concerns several product licences that contain amitriptyline, unfortunately, it would take us more than 24 working hours to locate, retrieve and extract the information.
We advise that you narrow your request, for example, by restricting your FOI request to one specific product licence that you would like the clinical study reports for.
Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that section 12 could still apply.
The following link of our website page below provides information on Public Assessment Reports (PARs) and this tool can be used to search for PARs for the products you are interested in. https://products.mhra.gov.uk/
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review would be carried out by a senior member of the Agency who was not involved with the original decision.
If you have a query about the information provided, please reply to this email.
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000