MHRA updates of clinical trial statuses on EudraCT

Till Bruckner made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,

several trial sponsors in the UK have indicated in interviews that in the past, they sometimes notified MHRA of the end of a CTIMP clinical trial as required, but that MHRA subsequently failed to update that trial's status on EudraCT.

As a result, many clinical trials conducted in the UK in the past are falsely listed as "ongoing" on EudraCT even though they have long ago been completed.

Questions:

1. Has the MHRA conducted a review of end-of-trial notifications received in the past to identify all cases in which trials are currently falsely listed as "ongoing" on EudraCT despite MHRA having received an end of trial notification?

2. Is MHRA working to update the status of completed UK trials listed falsely as "ongoing" on EudraCT?

3. What steps has MHRA taken to ensure that in future, end of trial notifications received will be consistently processed and EudraCT status updates made?

Yours faithfully,

Till Bruckner on behalf of TranspariMED
www.TranspariMED.org

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 19/014

Dear Till Bruckner,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 8 January 2019.


I confirm that your request is 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,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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FOILicensing, Medicines and Healthcare products Regulatory Agency

Dear Dr Bruckner

 

Thank you for your email of 8 January 2019 requesting information on MHRA
updates of clinical trial statuses on EudraCT.

 

Please find responses to your questions below:

 

1. Has the MHRA conducted a review of end-of-trial notifications received
in the past to identify all cases in which trials are currently falsely
listed as "ongoing" on EudraCT despite MHRA having received an end of
trial notification?

We can confirm that we have conducted such a review. Unfortunately, due to
historic resource issues, a backlog exists that we are currently working
through.

 

2. Is MHRA working to update the status of completed UK trials listed
falsely as "ongoing" on EudraCT

Yes; we have a plan in place and we have recently recruited an
administrator who has been tasked with this work. 

 

3. What steps has MHRA taken to ensure that in future, end of trial
notifications received will be consistently processed and EudraCT status
updates made?

Moving forward, in parallel with managing the backlog, our process will
involve the MHRA Clinical Trials Unit updating EudraCT on a weekly basis
with those end-of-trial notifications received during that week. In the
longer term, the UK government has confirmed that the UK will align with
the new EU Clinical Trials Regulation which will provide further
transparency on the status of the trial. Under these regulations, the
start of the clinical trial, the end of the recruitment of subjects for
the clinical trial and the end of the clinical trial (in that Member
State, in all Member States, and in all third countries) will be notified
by the sponsor directly in the IT system.

 

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 of receipt of the response to your
original email, and can be made by response to this email address. Please
remember to quote the reference number above in any future communications.

 

If you are not content with the outcome of the internal review, you have
the right to apply directly to the Information Commissioner for a
decision. The Information Commissioner can be contacted at: Information
Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9
5AF.

 

Yours Sincerely,

 

Customer Services

Communications division

Medicines and Healthcare products Regulatory Agency

151 Buckingham Palace Road, London, SW1W 9SZ

Telephone: 020 3080 6000

 

 

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