Clinical Trials Reporting

Debra Winberg made this Rhyddid Gwybodaeth request to Hull University Teaching Hospitals NHS Trust

This request has been closed to new correspondence. Contact us if you think it should be reopened.

Roedd y cais yn rhannol lwyddiannus.

Dear Hull and East Yorkshire Hospitals 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 2016-004803-30 is completed, but has no reported results.

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 Hull and East Yorkshire Hospitals 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

Freedom of Information Requests,

Thank you for your e-mail.  This is an automated response to let you know
that your Freedom of Information (FOI) request has been received by Hull
and East Yorkshire Hospitals NHS Trust, Freedom of Information Team. No
further acknowledgement will be sent.

If your request does not constitute a request under the Act we will advise
you of an alternative course of action, or we may redirect your message,
but we will advise you.

Valid FOI requests will receive a response within the statutory timescale
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Please bear this in mind when you calculate the “due date” for your
request.

Our response will provide you with the information you have requested or
explain why it has not been provided quoting any Exemptions that apply.

Kind Regards
Freedom of Information Team

Hull and East Yorkshire Hospitals NHS Trust

 

Dear Hull and East Yorkshire Hospitals NHS Trust,

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 faithfully,

Debra Winberg

Freedom of Information Requests,

Thank you for your e-mail.  This is an automated response to let you know
that your Freedom of Information (FOI) request has been received by Hull
and East Yorkshire Hospitals NHS Trust, Freedom of Information Team. No
further acknowledgement will be sent.

If your request does not constitute a request under the Act we will advise
you of an alternative course of action, or we may redirect your message,
but we will advise you.

Valid FOI requests will receive a response within the statutory timescale
of 20 working days. This is calculated as follows:-

•  20 working days is counted from the next working day after your request
was deemed to be received.
•  Public holidays and recognised non-working days, ie. Saturdays and
Sundays are not classified as working days.
•  Standard office hours are 9 a.m. to 5 p.m. Requests received after 5
p.m. will be deemed to have arrived the next working day.
Please bear this in mind when you calculate the “due date” for your
request.

Our response will provide you with the information you have requested or
explain why it has not been provided quoting any Exemptions that apply.

Kind Regards
Freedom of Information Team

Hull and East Yorkshire Hospitals NHS Trust

 

Freedom of Information Requests,

2 Atodiad

Dear Debra Winberg

Please find attached the response to your Freedom of Information Request.  We apologise for the delay.

The information we have provided to you is copyrighted to the Hull University Teaching Hospitals NHS Trust and provided to you free of charge for your personal use or for other specific uses permitted in the Copyright Act. If however you wish to use the information we have provided for any commercial purposes including the sale of the information to a third party then, under the Regulations on the Re-use of Public Sector Information Regulations 2005, you must ask us for permission to do so in respect of each specific piece of such information. If we do grant such permission this may involve a licensing arrangement which may attract a fee.

All information provided under Freedom of Information is deemed to be in the public domain.
If you are unhappy with the service you have received in relation to your request and wish to make a complaint or request a review of our decision you should write to:

Freedom of Information Team
Hull University Teaching Hospitals NHS Trust
[Hull University Teaching Hospitals NHS Trust request email]

If you are not content with the outcome of your complaint, you may apply directly to the Information Commissioner for a decision. Generally, the ICO cannot make a decision unless you have exhausted the complaints procedure provided by the Hull University Teaching Hospitals NHS Trust. The Information Commissioner can be contacted at:

The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

Freedom of Information Team
Hull University Teaching Hospitals NHS Trust
Suite 19, Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ

[Hull University Teaching Hospitals NHS Trust request email]