Dear University Hospitals of Leicester NHS Trust,

By aggregating data from the EU trials registry, the EU Trials Tracker has identified 57 clinical trials sponsored by the Trust:
http://eu.trialstracker.net/sponsor/univ...

The scope of this request covers the 57 trials listed by the EU Trials Tracker as of today.

1. Please provide a list of all trials out of the 57 listed by the tracker that were completed before 31 December 2017, together with each trial's correct completion date. (In this context, please note that a total of 38 trials are listed as "not due" by the tracker, based on registry data. However, it is clear that many of the trials publicly listed as not due have in fact been completed over a year ago; thus, accurate trial completion data is not publicly available.)

2. For all trials listed in response to question (1), please provide hyperlink(s) to where their outcomes have been published. "Published" in this context refers to summary results published on the EU registry, and/or publication in a peer-reviewed journal. It excludes all other forms of publication, such as presentations or conference abstracts.

3. For all trials listed in response to question (1), please state the name of the trial funder [funding source].

4. For all trials listed in response to question (1), please state the funding amount received, in GBP. If the trial was funded as part of a larger research project, please provide (a) the funding amount received for the overall research project, and (b) the estimated amount spent by the Trust on conducting the trial.

5. By when does the Trust plan to have updated its EU registry entries and posted summary results for all clinical trials completed >12 months ago, and who is responsible for managing this work?

Please provide the data requested in Q1-4 in one consolidated Excel sheet, using EudraCT numbers (rather than trial titles) to identify individual trials. Please answer Q5 narratively.

This FOI request is being filed on behalf of TranspariMED:
www.TranspariMED.org

Yours faithfully,

Till Bruckner

Dear University Hospitals of Leicester NHS Trust,

FYI here an excellent response to the same questions from another NHS Trust:
https://www.whatdotheyknow.com/request/r...

Yours faithfully,

Till Bruckner

FOI - Freedom of Information, University Hospitals of Leicester NHS Trust

1 Attachment

Our Reference: GB/FOI/40454

 

14 January 2019

 

Till Bruckner

[1][FOI #543344 email]

 

Dear Mr Bruckner

 

Request for Information

 

Thank you for your request for information, as received by University
Hospitals of Leicester NHS Trust on 9 January 2019. Within UHL NHS Trust,
Freedom of Information Act requests are managed centrally by the Corporate
and Committee Services Team. 

 

The Trust will endeavour to provide a response within the required 20
working-day deadline.  I will, of course, keep you informed should this
not prove possible for any reason. If we require any clarification on your
request, we will contact you as soon as possible.

 

All requesters are advised that the Trust may make a charge for providing
the information to them, to cover the cost of photocopying, postage and
packaging etc – I confirm that where these costs are below £5.00 in total,
no charge will be made.  All requesters are also advised that there may
also be a charge payable to cover costs of locating the information they
have requested, as laid down in the Freedom of Information Act Regulations
published by the Government in December 2004.  Naturally, if such a charge
is to be applied to your request, you will be informed as soon as
possible.

 

Yours sincerely,

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Luke Saunders

Litigation/Corporate and Committee Services

* Belgrave House, Leicester General Hospital, LE5 4PW

(  0116 258 8932/8610

8   [3][email address]

 

Information contained in emails may be subject to disclosure under the
Freedom of Information Act 2000, and confidentiality cannot therefore be
guaranteed.  Please ensure that all emails are accurate and appropriate,
and are retained/deleted in accordance with good practice and any policies
of the Trust.  If you are not the intended recipient of this email, please
inform the sender, delete the email from your system and destroy any
copies you may have made

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FOI - Freedom of Information, University Hospitals of Leicester NHS Trust

1 Attachment

Corporate and Legal Affairs – Corporate and Committee Services

 

Our Reference: GB/FOI/40454

 

5 February 2019

 

Till Bruckner

[1][FOI #543344 email]

 

Dear Till Bruckner

 

Request for Information

 

Thank you for your Freedom of Information Act (FOI) request, as received
on 9 January 2019 and acknowledged on 14 January 2019. For information,
the University Hospitals of Leicester NHS Trust is one of the largest and
busiest NHS teaching Trusts in the country incorporating the Leicester
Royal Infirmary, Glenfield and Leicester General Hospitals. Our three
hospitals have around 15,000 staff serving around 1.2 million people
across Leicester, Leicestershire and Rutland, and a further two to three
million people from the rest of the UK who come to us for treatment from
one of our specialist services.  During 2017/18 we treated 1,410,500
patients - that’s 3,864 patients each day.

 

Following consultation with colleagues from the Research and Innovation
team, I confirm that the University Hospitals of Leicester NHS Trust holds
information covered by your FOI request.   Your Freedom of Information Act
is set out in bold below, followed by the Trust’s response:

 

1. Please provide a list of all trials out of the 57 listed by the tracker
that were completed before 31 December 2017, together with each trial's
correct completion date. (In this context, please note that a total of 38
trials are listed as "not due" by the tracker, based on registry data.
However, it is clear that many of the trials publicly listed as not due
have in fact been completed over a year ago; thus, accurate trial
completion data is not publicly available.)

 

2. For all trials listed in response to question (1), please provide
hyperlink(s) to where their outcomes have been published. "Published" in
this context refers to summary results published on the EU registry,
and/or publication in a peer-reviewed journal. It excludes all other forms
of publication, such as presentations or conference abstracts.

 

3. For all trials listed in response to question (1), please state the
name of the trial funder [funding source].

 

4. For all trials listed in response to question (1), please state the
funding amount received, in GBP. If the trial was funded as part of a
larger research project, please provide (a) the funding amount received
for the overall research project, and (b) the estimated amount spent by
the Trust on conducting the trial.

 

5. By when does the Trust plan to have updated its EU registry entries and
posted summary results for all clinical trials completed >12 months ago,
and who is responsible for managing this work?

 

I am advised that some of the trials date back several years and that much
of the research and innovation data has been archived. To obtain the
information requested by you, each file would need to be retrieved and
reviewed, and in some cases the chief investigator (who may or may not
still work for the Trust) might also need to be contacted.  The Trust’s
Assistant Director of Research and Development estimates that at least 1
hour’s work would be required per trial, amounting to a total therefore of
57 hours.  This exceeds the ‘appropriate limit’ of 18 hours provided for
under the Freedom of Information Act 2000, and in reliance on section 12
of that Act the Trust will not be progressing your request further.  It
may be that if you were able to refine your request, there might be
information which could be provided to you within that 18-hour
‘appropriate limit’.

 

 

I am sorry that the Trust is unable to provide you with information on
this occasion. If you require any further assistance please do not
hesitate to contact me.  If you are dissatisfied with the Trust’s
response, you can contact the Director of Corporate and Legal Affairs on
Tel. No. 0116 258 8615 to request a copy of UHL’s Freedom of Information
Act complaints procedure.

 

We must advise you that where we have provided information we have done so
subject to the provisions of the Re-use of Public Sector Information
Regulations 2005.  Accordingly you must not re-use this information
without having the consent of the Trust.  Where the Trust is prepared to
provide its consent then it may levy a charge for doing so. Should you
wish to re-use documents provided then you must make your request in
writing stating your name and your address for correspondence together
with the document that you wish to re-use and the purpose for which the
information is to be re-used.

 

In the event that you remain dissatisfied with the way in which the Trust
has handled any complaint that you may wish to make, we would advise you
of your right to complain to the Information Commissioner at the
Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow,
Cheshire, SK9 5AF.

 

Yours sincerely,

(sent on behalf of Gill Belton, Corporate and Committee Services Officer)

 

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Helen Stokes

Corporate and Committee Services Manager

Belgrave House, Leicester General Hospital site

University Hospitals of Leicester NHS Trust

Tel: 0116 258 8590

 

Information contained in emails may be subject to disclosure under the
Freedom of Information Act 2000, and confidentiality cannot therefore be
guaranteed.  Please ensure that all emails are accurate and appropriate,
and are retained/deleted in accordance with good practice and any policies
of the Trust.  If you are not the intended recipient of this email, please
inform the sender, delete the email from your system and destroy any
copies you may have made.

 

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