Dear University Hospitals of Leicester NHS Trust,

A review of the clinical trials sponsored by the Trust listed on the EudraCT trial registry shows that some of the data provided there is incomplete and/or inaccurate.

For example, trial 2006-001065-41 is listed as ongoing but has a completion date.

Therefore, the information requested in this FOI is currently not available from the EudraCT registry or from other public sources.

1. Please confirm that all trials sponsored by the Trust that are listed on EudraCT as "ongoing" are in fact still ongoing as of today. If not, please provide a list of all trials whose "ongoing" status on EudraCT is currently incorrect, together with the actual completion date of each trial.
2. For each trial sponsored by the Trust that is listed on EudraCT whose actual completion date lies more than 12 months in the past (i.e. all trials identified as due by the EU Trials Tracker plus all trials identified as completed >=12 months ago in response to question 1) and for which results are still missing on EudraCT itself, please provide links to where their outcomes have been published in the academic literature and/or on other trial registries.
3. Please state who the funder is for those trials whose funder information is missing from clincaltrials.gov.
4. For each trial, individually, please state the funding amount received for the trial, in British Pounds (GBP). If a trial was conducted as part of a larger research effort, please make a note of this in the Excel, and provide the funding amount (in GBP) received for the larger research effort.
5. Please state by what date University Hospitals of Leicester NHS Trust expects to have completed the process of posting the missing trial results for all currently due interventional clinical trials (i.e. trial was completed >=12 months ago) onto (a) EudraCT, (b) Clinicaltrials.gov, and (c) ISRCTN

Please feel free to put your responses in an Excel spreadsheet with the trial ID in A, the clinicaltrials.gov ID number in B if applicable, the ISRCRTN in column C, the trial name in D, the current status in EudraCT in E, the actual status in F, the estimated end of trial date in G, the date EudraCT will be updated in H, publications in I, funder information in J, and amount funded in K

Yours faithfully,

Debra Winberg

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

1 Attachment

Our Reference: HM/FOI/40484

 

21 January 2019

 

Debra Winberg

[1][FOI #546184 email]

 

Dear Ms Winberg,

 

Request for Information

 

Thank you for your request for information, as sent on Sunday 20 January
2019 and received by University Hospitals of Leicester NHS Trust on the
next working day which was Monday 21 January 2019. Within UHL NHS Trust,
Freedom of Information Act requests are managed centrally by the Corporate
and Committee Services Team, and I confirm that your request is now being
handled under the Freedom of Information Act 2000.

 

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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Dear FOI - Freedom of Information,
The response to my request has been delayed, by law this should have been responded to promptly. The information I requested on clinical trial reporting and funding has important policy implications and therefore the data is valuable for me and the public to have.

If you have any questions about the information I need please feel free to respond.

Yours sincerely,

Debra Winberg

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

1 Attachment

Corporate and Legal Affairs – Corporate and Committee Services

 

Our Reference: HM/FOI/40484

 

18 February 2019

 

Dear Ms Winberg

 

Request for Information

 

Thank you for your Freedom of Information Act (FOI) request, as sent on
Sunday, 20 January 2019, received by the Trust on the next working day,
Monday, 21 January 2019 and acknowledged on the same day. 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
Directorate, I confirm that the University Hospitals of Leicester NHS
Trust holds information covered by your FOI request.   In your Freedom of
Information Act request, you asked for the following information and the
Trust’s response is provided below your request:-  

 

A review of the clinical trials sponsored by the Trust listed on the
EudraCT trial registry shows that some of the data provided there is
incomplete and/or inaccurate.

 

For example, trial 2006-001065-41 is listed as ongoing but has a
completion date.

 

Therefore, the information requested in this FOI is currently not
available from the EudraCT registry or from other public sources.

 

 1. Please confirm that all trials sponsored by the Trust that are listed
on EudraCT as "ongoing" are in fact still ongoing as of today. If not,
please provide a list of all trials whose "ongoing" status on EudraCT
is currently incorrect, together with the actual completion date of
each trial.

 

 2. For each trial sponsored by the Trust that is listed on EudraCT whose
actual completion date lies more than 12 months in the past (i.e. all
trials identified as due by the EU Trials Tracker plus all trials
identified as completed >=12 months ago in response to question 1) and
for which results are still missing on EudraCT itself, please provide
links to where their outcomes have been published in the academic
literature and/or on other trial registries.

 

 3. Please state who the funder is for those trials whose funder
information is missing from clincaltrials.gov.

 

 4. For each trial, individually, please state the funding amount received
for the trial, in British Pounds (GBP). If a trial was conducted as
part of a larger research effort, please make a note of this in the
Excel, and provide the funding amount (in GBP) received for the larger
research effort.

 

 5. Please state by what date University Hospitals of Leicester NHS Trust
expects to have completed the process of posting the missing trial
results for all currently due interventional clinical trials (i.e.
trial was completed >=12 months ago) onto (a) EudraCT, (b)
Clinicaltrials.gov, and (c) ISRCTN

 

The Trust’s response is:-

 

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 this work
would take between 50-60 hours – significantly in excess of the
appropriate 18-hour limit provided for under the Freedom of Information
Act. It may be, however, that if you were to refine your request the Trust
may be able to provide some information to you within the 18-hour limit.

 

I am further advised that steps have already been taken to ensure the
information on EudraCT is updated as soon as possible.

  

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,

 

Hina Majeed

Corporate and Committee Services Officer

Hina Majeed
Corporate and Committee Services Officer
University Hospitals of Leicester NHS Trust
Belgrave House
Leicester General Hospital
Leicester LE5 4QF

Email: [1][email address]

Information contained in e-mails may be subject to disclosure under the
Freedom of Information Act 2000, and confidentiality cannot therefore be
guaranteed.  Please ensure that all e-mails 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 e-mail,
please inform the sender, delete the e-mail from your system and destroy
any copies you may have made.

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Dear University Hospitals of Leicester NHS Trust,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of University Hospitals of Leicester NHS Trust's handling of my FOI request 'Clinical Trials Reporting'.

Thank you so much for your dedication to updating the trials on online trackers and reporting all your trials. However, I have some concerns considering the response to my FOI. I was informed that some trials were archived and hard to find and that in total it would take more than 18 hours to get the information. While I understand this, where did this calculation of time come from, as other trusts were able to get me the information. Additionally, is there a way to get the information for trials that are not archived and easy to access as any information is better then none.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/c...

Yours faithfully,

Debra Winberg

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

Our Reference SM/FOI/40484R
Date : 08 March 2019
Dear Madam
INTERNAL REVIEW OF HANDLING OF REQUEST MADE UNDER THE FREEDOM OF INFORMATION ACT 2000 (the "Act")
1. BACKGROUND
1.1 On 20th January 2019 the Trust received a request under the Act from the Applicant.
1.2 The following information was requested:
A review of the clinical trials sponsored by the Trust listed on the EudraCT trial registry shows that some of the data provided there is incomplete and/or inaccurate.

For example, trial 2006-001065-41 is listed as ongoing but has a completion date.

Therefore, the information requested in this FOI is currently not available from the EudraCT registry or from other public sources.

1. Please confirm that all trials sponsored by the Trust that are listed on EudraCT as "ongoing" are in fact still ongoing as of today. If not, please provide a list of all trials whose "ongoing" status on EudraCT is currently incorrect, together with the actual completion date of each trial.
2. For each trial sponsored by the Trust that is listed on EudraCT whose actual completion date lies more than 12 months in the past (i.e. all trials identified as due by the EU Trials Tracker plus all trials identified as completed >=12 months ago in response to question 1) and for which results are still missing on EudraCT itself, please provide links to where their outcomes have been published in the academic literature and/or on other trial registries.
3. Please state who the funder is for those trials whose funder information is missing from clincaltrials.gov.
4. For each trial, individually, please state the funding amount received for the trial, in British Pounds (GBP). If a trial was conducted as part of a larger research effort, please make a note of this in the Excel, and provide the funding amount (in GBP) received for the larger research effort.
5. Please state by what date University Hospitals of Leicester NHS Trust expects to have completed the process of posting the missing trial results for all currently due interventional clinical trials (i.e. trial was completed >=12 months ago) onto (a) EudraCT, (b) Clinicaltrials.gov, and (c) ISRCTN

Please feel free to put your responses in an Excel spreadsheet with the trial ID in A, the clinicaltrials.gov ID number in B if applicable, the ISRCRTN in column C, the trial name in D, the current status in EudraCT in E, the actual status in F, the estimated end of trial date in G, the date EudraCT will be updated in H, publications in I, funder information in J, and amount funded in K

1.3 In its reply of 18 February 2019 the Trust indicated that it was entitled to rely on S12 of the Act. The Trust gave an explanation of that section and went on to explain how it had applied that section.
1.4 On 26 February 2019 the Applicant requested an internal review of the handling of the request.
2. THE REVIEW
2.1 I have now conducted a review of the handling of your request. In doing so I have followed the internal procedures of the Trust and have had regard to all the relevant facts and circumstances. In particular I have considered:
2.1.1 The Freedom of Information Act 2000;
2.1.2 The requests dated 20 January 2019 and the response to that request;
2.1.3 All correspondence and documents including the material which was provided;
2.1.4 Guidance of the Information Commissioner;
3 FINDINGS

3.1 Procedural Findings

3.1.1 The 20 working day statutory timeframe for compliance was complied with.
3.1.2 The Trust's response met the requirements set out in section 17 of the Act. The response stated that information was exempt, specified the exemption in question, and stated why that exemption applied. The response included details of the right to request an internal review and the right to appeal to the Information Commissioner.
3.2 Substantive Findings
3.2.1 Section 12 (Applicable Amount)
3.2.1.1 I consider that the information was withheld appropriately.
3.2.1.2 Where Section 12 is relied upon it is incumbent upon the Trust to make appropriate enquires for proper persons to establish the Time Estimate. In this case the Trust obtained its Time Estimate from the Head of the Department which manages the information requested which I find to be sufficient.
3.2.1.3. I reiterate the suggestion made in the response to the request that if the Requester should refine her request then it may be possible to provide information. Alternatively I understand that steps have already been taken, or will shortly occur, to ensure that the information on EudraCT will be updated and the requester should consider making contact with those with responsibility for the content EudraCT.
4. CONCLUSION
Following the Review I am not disclosing further information.
If you are not content with the outcome of your complaint, you may 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

Steve Murray
Assistant Director of Corporate and Legal Affairs

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