UK clinical trials of medical devices

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

Nadine Dorries, Minister of State (Department of Health and Social Care), recently stated that:

"All trials of new medical devices being developed for the United Kingdom market are reviewed by the MHRA before the devices are used on humans in these trials in the UK. The MHRA maintains a record of all such trials whether approved or refused. Plans are in place to make this information available to the public in future."
https://www.theyworkforyou.com/wrans/?id...

Questions:

1. Please provide an Excel spreadsheet listing all such trials that have been approved since 01 January 2006. The Excel should at a minimum include the WHO primary registry number (e.g. NTC123456789, ISRCTN01020304) of each such trial. If these data are not available for the entire time span, please provide what data are available.

2. Please detail what steps (if any) the MHRA takes to (a) detect which of these trials that have been approved and completed but have not made their outcomes public on a trial registry or in a peer reviewed academic journal, and (b) obtain the outcomes of such unpublished trials.

3. By what date does the MHRA intend to proactively make information on such trials available to the public?

Yours faithfully,

Till Bruckner

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 20/323

       
Dear Till Bruckner,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 16 September 2020. 
     
I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt. 

If you need to contact us again about this request, please quote the reference number above.
        
Kind Regards,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

FOI 20/323
 
Dear Till Bruckner,
 
Thank you for your information request, dated 16^th September 2020, where
you asked for:
 
1. Please provide an Excel spreadsheet listing all such trials that have
been approved since 01 January 2006. The Excel should at a minimum include
the WHO primary registry number (e.g. NTC123456789, ISRCTN01020304) of
each such trial. If these data are not available for the entire time span,
please provide what data are available.
 
2. Please detail what steps (if any) the MHRA takes to (a) detect which of
these trials that have been approved and completed but have not made their
outcomes public on a trial registry or in a peer reviewed academic
journal, and (b) obtain the outcomes of such unpublished trials.
 
3. By what date does the MHRA intend to proactively make information on
such trials available to the public?.
 
We are pleased to provide you with some of the information requested, see
below.
 
We can confirm that we do not hold the WHO primary registry numbers that
you have requested.
 
We do not detect which approved studies have made their outcomes public.
 
We do request copies of the final reports for all approved clinical
investigations.
 
The Medicines & Medical Devices Bill currently going through parliament
will give MHRA the power to update and amend the legislative frameworks
that governs human medicines, medical devices and veterinary medicines.
This will enable legislative changes to do what’s best for the UK, to
support innovation and protect patients. These powers will also enable
transparency to support patient safety work. Clinical investigations work
will be part of these future considerations. MHRA do not have any
definitive timescales at this stage.
 
Unfortunately, some of the information is exempt from release under
section 44:
 
Section 44 – Prohibitions on disclosure: the release of information is
exempt as its disclosure is prohibited by other legislation. In this case,
section 237 of the Enterprise Act 2002 prohibits a public authority from
releasing information which came to it in connection with the exercise of
its functions, and which relates to the affairs of an individual or
business.
 
The MHRA is satisfied that the information you have requested:

* constitutes information which came to us in connection with the
exercise of the Agency’s functions. The MHRA has a duty of consumer
protection under the Consumer Protection Act 1987 which is listed as a
specified function under Schedule 14 of the Enterprise Act 2002, and
receives information while exercising consumer protection functions in
its role as the regulator of medicines and healthcare products. 
* relates to the affairs of businesses which continue to exist.

On that basis we are satisfied that section 44 of FOI Act applies and the
information is exempt from release. 
 
 
The Freedom of Information Act only entitles you access to information –
the information supplied is subject to Crown copyright, and there are some
restrictions on its re-use. For information on the reproduction or re-use
of MHRA information, please visit
[1]https://www.gov.uk/government/publicatio....
 
Please remember to quote the reference number above in any future
communications.
 
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 will be carried out by a senior member of the Agency
who was not involved with the original decision.
 
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 Services
 
 
 
 

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