MHRA updates of clinical trial statuses on EudraCT - progress

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Dear Medicines and Healthcare products Regulatory Agency,

This FOI response is being filed on behalf of TranspariMED.

In response to an FOI titled "MHRA updates of clinical trial statuses on EudraCT" submitted on 8 January 2019 (Ref: FOI 19/014), MHRA reporting ongoing work to update the status of completed UK trials falsely listed as "ongoing" on EudraCT.

While there appears to have been significant progress in this regard since then, some MHRA-regulated trials on EudraCT continue to have outdated, incorrect or missing status data.

Examples:
2019-004085-17 (no status provided on register)
2006-004442-16 (completed, but no date, and reported results)
2004-002051-13 and 2005-001525-28 (marked as "ongoing" even though they seem likely to have been completed long ago)

Please provide the following information:

1. By what date did MHRA complete, or does MHRA expect to complete, the review process described in response to FOI 19/014?

2. What is the # and % of MHRA regulated trials for which MHRA assumes status information on EudraCT is currently up to date, correct and complete?

3. What is the # and % of MHRA regulated trials for which MHRA assumes status information on EudraCT is currently not up to date, correct and complete?

4. What is the # and % of MHRA regulated trials for which MHRA does not know whether or not status information on EudraCT is currently up to date, correct and complete?

5. Are there any trials for which MHRA is unable to ensure that the status is up to date, correct and complete? If yes, please briefly outline the characteristics of such trials, and provide the # and % (or, if precise figures are not available, estimated # and %) of such trials.

6. What have been, or are, the main barriers to ensuring that the status of all trials listed on EudraCT is up to date, correct and complete?

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 20/273

Dear Till Bruckner,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 6 July 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 20/273
 
 
Dear Dr Bruckner,
 
Thank you for your email of 5th July 2020, in which you requested the
following information under the Freedom of Information (FOI) Act 2000:
 
asking for information on the progress of MHRA updates of clinical trial
statuses on EudraCT.
We have responded to your queries below.
 
1. By what date did MHRA complete, or does MHRA expect to complete, the
review process described in response to FOI 19/014?
We have reviewed 12,692 “Declaration of the End of Trial” forms received
by MHRA and, for the vast majority of the declarations, had checked that
the status of each of these was correctly showing in EudraCT by November
2019.  Please see below for further details.
 
2. What is the # and % of MHRA regulated trials for which MHRA assumes
status information on EudraCT is currently up to date, correct and
complete?
Of the 12,692 “Declaration of the End of Trial” forms reviewed by MHRA,
12,587 (99.2%) are up to date on the database.  (This does not include
trials started prior to the implementation of the Clinical Trials
Directive.)
 
3. What is the # and % of MHRA regulated trials for which MHRA assumes
status information on EudraCT is currently not up to date, correct and
complete?
Of the 12,692 “Declaration of the End of Trial” forms reviewed, we know
that the status of 105 trials (0.8%) is currently not up to date on the
EudraCT database.  We are also aware that there are 1,847 trials in the
public register that have results attached but still have a status of
‘ongoing’.  We assume MHRA has not been notified via an End of Trial form
that these studies have completed and we are addressing these as part of a
separate activity. 
 
4. What is the # and % of MHRA regulated trials for which MHRA does not
know whether or not status information on EudraCT is currently up to date,
correct and complete?
As you have pointed out in your correspondence there are ‘old’ trials in
the public register listed as ongoing but for which it could be assumed
are actually completed and the sponsor has not notified the regulator.  It
is not possible to estimate a figure for these. We will continue to
address and update these as part of the activity as described in response
to #3.
 
5. Are there any trials for which MHRA is unable to ensure that the status
is up to date, correct and complete? If yes, please briefly outline the
characteristics of such trials, and provide the # and % (or, if precise
figures are not available, estimated # and %) of such trials.
Please see the response to #4
 
6. What have been, or are, the main barriers to ensuring that the status
of all trials listed on EudraCT is up to date, correct and complete?
The largest barrier we encountered was ensuring XML files were available
and valid for the current version of EudraCT.  This necessitated dialogue
with the EMA service desk and the trial sponsor.  Another barrier is
frequent periods of downtime/maintenance of the EudraCT database.
 
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Medicines and Healthcare Products Regulatory Agency
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MHRA Customer Service Centre
 
Medicines and Healthcare products Regulatory Agency
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