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Clinical trial reporting in UK NHS trusts

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Florence Rodgers

Dear London North West University Healthcare NHS Trust,

According to the EU Trials Tracker, your institution has still not made public the results of 6 clinical trials on the European registry. http://eu.trialstracker.net/?search.

For example, your clinical trial 2008-006846-24 has been terminated more than a year ago, but your institution has not yet made its results public.
Please note that the MHRA’s post-Brexit transparency rules require UK trial sponsors to continue uploading the results of completed drug trials onto the European registry.

Under the Freedom of Information Act 2000 can you please respond to the following questions:

1. What steps is your institution currently taking to make the results of these clinical trials public on the European trial registry?
2. By when does your institution plan to have made public the results of all due trials on the registry?
3. What steps has your institution taken to ensure that in future, all clinical trial results will be made public on trial registries within 12 months of trial completion?
4. Why was trial 2008-006846-24 terminated and where are the results available?
5. Why was trial 2007-000008-34 terminated and where are the results available?
6. Where are the results of the following trials: 2005-004423-19, 2005-002101-23, 2005-001975-37, 2005-000680-26?

Please note that the MHRA’s post-Brexit transparency rules require UK trial sponsors to continue uploading the results of completed drug trials onto the European registry.

Yours faithfully,

Florence Rodgers

FOI (LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST), London North West University Healthcare NHS Trust

Dear Sir/Madam,

 

+------------------------------------------------------------------------+
|*Please note that in light of the ongoing pandemic, your request for |
|information may be delayed due to urgent operational responses in |
|dealing with Public Health priorities.  |
+------------------------------------------------------------------------+

 

Thank you for your recent email to London North West University Healthcare
NHS Trust, which I can confirm is being treated as a FOI (Freedom of
Information) request.

 

Our reference number for this request is 4308-21 (*please quote this on
all correspondence)

 

Should you have any further queries or information related to this
request, please do not hesitate in replying to this email.

 

Kind regards

 

FOI Team

London North West University Healthcare NHS Trust

[1][email address]

 

 

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FOI (LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST), London North West University Healthcare NHS Trust

Dear Florence Rodgers,

 

FOI Ref: 4308-21 (*Please quote this reference number on all
correspondence)

 

Please find below the response to your Freedom of Information request to
London North West University Healthcare NHS Trust.

 

You may re-use this information (except for logos) under the terms of the
Open Government Licence^1.  If you would prefer to receive the information
in an alternative electronic format, please let us know.

 

Please let us know if you require more details or further clarification. 
You can find out more about the Trust and our publication scheme at our
website^2.

 

I am now in a position to respond to your noted questions/query as
follows;

 

According to the EU Trials Tracker, your institution has still not made
public the results of 6 clinical trials on the European registry.
[1]http://eu.trialstracker.net/?search.

 

For example,  your clinical trial 2008-006846-24 has been terminated more
than a year ago, but your institution has not yet made its results public.

 

Please note that the MHRA’s post-Brexit transparency rules require UK
trial sponsors to continue uploading the results of completed drug trials
onto the European registry.

 

1.       What steps is your institution currently taking to make the
results of these clinical trials public on the European trial registry?

 

Where results are available, these have been published.  However, some
primary record holders have since left the Trust and the Trust did contact
EMEA to transfer ownership of these accounts to a designated Research &
Development (R&D) contact to manage and update the clinic trial records.

 

2.       By when does your institution plan to have made public the
results of all due trials on the registry?

 

We will ensure all due trials have their results published as soon as
possible and within 12 months of the trial closing.

 

3.       What steps has your institution taken to ensure that in future,
all clinical trial results will be made public on trial registries within
12 months of trial completion?

 

The Trust has systems and procedures in place to ensure that it can adhere
to international clinical trial regulations and has developed and action
plan along with a communications plan to promote clinical trial
transparency to all staff, patients and service users.

 

Since March 2019, the R&D department has been liaising closely with the
Health Research Authority (HRA) to address clinical trials which require
action and has written to the EMEA to assign the trial records to a
designated contact within the R&D department, so that the Trust can manage
and complete the records as the current account holders are no longer
employed at the Trust. Upon review of the clinical trial tracker, there
are currently four records which require attention, which both the EMEA
and HRA have been informed of as three terminated early due to recruitment
barriers and at least one trial never went ahead, however the EU Clinical
Trial Register does not provide an option to indicate this

 

4.       Why was trial 2008-006846-24 terminated and where are the results
available?

 

The trial was terminated early because funding from the MRC was withdrawn
as the trial was unable to meet the recruitment target of 316 patients
within a reasonable time. Therefore, no results are available from this
trial as there was insufficient recruitment and data to reach the required
trial endpoints. The study team did however publish a research paper in
the BMJ explain the challenges with recruitment to this study and the
lessons learnt for future research in recruitment strategies for trials in
sickle cell disease, which can be accessed at:

 

[2]https://pubmed.ncbi.nlm.nih.gov/27288381/

 

5.       Why was trial 2007-000008-34  terminated and where are the
results available?

 

The trial was terminated early as no patients were recruited to the study.
There was no data available to reach the required end points of the trial
so no results are available.

 

6.       Where are the results of the following trials: 2005-004423-19,
2005-002101-23, 2005-001975-37, 2005-000680-26?

 

+-----------------------------------------------------------------------------------+
|EudrCT Number | Update on Results |
|--------------+--------------------------------------------------------------------|
|2008-006846-24| Trial closed early because it failed to randomise to its target of |
| | 316 patients within a reasonable time and funding was withdrawn. |
| | However the study team did publish a paper on the challenges of |
| | recruiting to a sickle cell |
| | trial [3]https://pubmed.ncbi.nlm.nih.gov/27288381/ |
|--------------+--------------------------------------------------------------------|
|2007-000008-34| No patients were recruited to this study and no analysis was |
| | conducted. Hence there are no results to report- 03.04.2019 |
|--------------+--------------------------------------------------------------------|
|2005-004423-19| Results published in 2008 in the gastrointestinal journal. 150 |
| | patients were randomised to the study. Bowel preparation +/or |
| |prokinetics does not significantly improve view quality, completion |
| | rates or diagnostic yield at small bowel CE although transit times |
| |may be reduced. Bowel preparation is less comfortable and therefore |
| | its use in routine cases is not currently indicated. |
| |[4]https://www.giejournal.org/article/S0016...
|--------------+--------------------------------------------------------------------|
|2005-002101-23| Study was abandoned and did not recruit, therefore there were no |
| | results to publish as no analysis was done |
|--------------+--------------------------------------------------------------------|
|2005-001975-37| Study recruited one patient, and terminated early as it became |
| | apparent the trial was not viable, therefore no results to publish |
| | as analysis was not done. MHRA was notified of this |
|--------------+--------------------------------------------------------------------|
|2005-000680-26| Results published in January 2010 in proceeding of nutrition |
| | society. Eleven patients completed both arms of the study. No |
| | difference was seen between the groups at randomisation. The study |
| | showed that taurine supplemented HPN when compared to taurine-free |
| |HPN did not significantly improve liver function. Nutritional status|
| | remained constant and no difference in complication rates was |
| | observed during the study |
+-----------------------------------------------------------------------------------+

 

*As noted as part of the Trust’s acknowledgement email, staff are
currently responding to urgent operational issues in dealing with Public
Health priorities, and therefore any further information you may require
to that provided, as above, may be subject to delay at this time.

I hope this information helps, however, should you be dissatisfied with
our response, please use our FOI review process by contacting
[5][email address] or writing to:

Information Governance Manager (FOI Review)

Information Governance

Northwick Park Hospital

P Block

Watford Road

Harrow

HA1 3UJ

 

Please be aware that reviews will not be conducted via public forum, and
we will require your name and contact address in order to respond.

 

If you remain dissatisfied after a review, you have the right under s50 of
the Act to apply to the Information Commissioner’s Office for a decision.

 

Further details about this and the Act can be found on their website^3.

 

^1 Either version 3 or, at your discretion, any later version –
[6]http://www.nationalarchives.gov.uk/doc/o...

^2 [7]https://www.lnwh.nhs.uk/about-us/freedom...

^3 [8]http://www.ico.org.uk

 

FOI Team

London North West University Healthcare NHS Trust

[9][email address]

 

 

*Please note that in line with ICO (Information Commissioner’s Office) FOI
(Freedom  of Information) guidance, the Trust reserves the right to:

 

·       Ask that all submissions include the real name of the person/s
making a request

·       Enquire about the requester’s motives (where the request is
ambiguous or unclear)

·       Enquire whether the information being sought is with a view to
being released into the public domain (e.g. MP, Media Outlet, Journalist)
especially in any

        instances where there is reason to believe that disclosure may be
likely to cause prejudice and/or harm

 

Further information in relation the Freedom of Information Act (Inc.
Exemptions and prejudice test) can be found via the ICO website at
[10]https://ico.org.uk

 

 

 

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We don't know whether the most recent response to this request contains information or not – if you are Florence Rodgers please sign in and let everyone know.