Data set that formed the basis for the Clinical Trial Registration Audit Report of September 2015

The request was successful.

Dear Health Research Authority,

could you please provide:

1. A copy of the full data set that formed the basis for the Clinical Trial Registration Audit Report of September 2015, including all lines and columns included in the original data set? If possible, please provide the data in Excel format.

2. A copy of the most recent version of the data set tracking the responses/results of HRA enquiries e-mailed to trial sponsors, as described in the Audit Report:
"For clinical trials approved since 30 September 2013 we will e-mail each sponsor where the clinical trial could not be located on a public register and request details of registration or if not registered, details of why the trial is not registered and confirmation that the trial will be registered."

Thank you for your time.

Yours faithfully,

Till Bruckner

FOI, HRA (HEALTH RESEARCH AUTHORITY),

Dear Mr Bruckner,

Thank you for your email dated 23 March 2018 requesting the following
information:

1.       A copy of the full data set that formed the basis for the
Clinical Trial Registration Audit Report of September 2015, including all
lines and columns included in the original data set? If possible, please
provide the data in Excel format.

2.       A copy of the most recent version of the data set tracking the
responses/results of HRA enquiries e-mailed to trial sponsors, as
described in the Audit Report:

"For clinical trials approved since 30 September 2013 we will e-mail each
sponsor where the clinical trial could not be located on a public register
and request details of registration or if not registered, details of why
the trial is not registered and confirmation that the trial will be
registered."

Your request is being handled under the Freedom of Information (FOI) Act
and has been referred to the appropriate personnel for investigation.  We
will provide you with a response as soon as possible, but no later than 24
April 2018.

Kind regards,

Stephen Tebbutt

Head of Corporate Governance

Freedom of Information

Health Research Authority

HRA | Skipton House, 80 London Road | London | SE1
6LH

T. 0207 972 2487

E. [1][email address]

W. [2]www.hra.nhs.uk

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FOI, HRA (HEALTH RESEARCH AUTHORITY),

2 Attachments

Dear Mr Bruckner,

Please find attached a response to your FOIA request.

Regards,

Freedom of Information
Health Research Authority
HRA | Skipton House, 80 London Road | London | SE1 6LH
T. 0207 972 2487
E. [email address]
W. www.hra.nhs.uk

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Dear FOI, Dear Stephen Tebbutt,

thank you for your timely response.

I am looking forward to learning the results of your public interest test deliberations and receivng additional data.

Yours sincerely,

Till Bruckner

Dear FOI, Dear Stephen Tebbutt,

as you consider the public interest test over the coming days and weeks, please take the following perspective into account:

"Previous investigations by STAT News and two trials trackers developed by the EBM Data Lab at Oxford University have demonstrated that greater visibility of trialists’ and institutions’ performance leads to significant improvements in their performance. Improving this performance is in the interests of patients, taxpayers, and public health agencies in the UK and beyond.

Considering the overwhelming public interest in curbing reporting bias and evidence distortion in medicine, we strongly hope that the Health Research Authority will take the logical next step towards improving transparency in the field, and decide to make its own audit findings transparent."

https://www.transparimed.org/single-post...

Yours sincerely,

Till Bruckner

FOI, HRA (HEALTH RESEARCH AUTHORITY),

1 Attachment

  • This attachment has been hidden. There are various reasons why we might have done this, sorry we can't be more specific here. Please contact us if you have any questions.

Dear Mr Bruckner,

Further to the previous correspondence I can confirm the public interest test has been completed and the HRA has found it is in the public interest to release this information.

It is important to flag the audit's methodology did not identify trials that hadn’t been registered; it identified trials where we were unable to identify they had been registered. It also included trials approved right at the end of the period audited, so they wouldn’t have started and therefore needn’t have registered yet. The report is explicit that:

•Where trials could not be located on a publicly accessible database, this does not necessarily mean that they have not been registered.
•The requirement to register is no later than 6 weeks after recruitment of the first participant and this time point may not have been reached at the time of searching.
•It is unlikely that studies will have commenced immediately after the favourable opinion has been issued; in which case there would be no expectation that these studies are registered at the point of audit
•Not finding the trial may have been due to the search method rather than the trial not having been registered

We hope that this information is helpful to you, but should you require further clarification, please let us know.

If you are unhappy about the way in which your request has been handled, the HRA has an internal complaints procedure through which you can raise any concerns. Further details of this procedure may be obtained by contacting the Complaints Manager via [email address]. If you are dissatisfied with the outcome of the complaints procedure, you can apply to the Information Commissioner’s Office (ICO), who will consider whether we, as a public authority, have complied with its obligations under the Act, and can require the HRA to remedy any problems. You can find out more about how to do this, and about the Act in general, on their website www.ico.org.uk. Complaints should be sent to:
FOI Complaints Resolution – Information Commissioner’s Office
Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF

Kind regards,

Stephen Tebbutt
Head of Corporate Governance

Freedom of Information
Health Research Authority
HRA | Skipton House, 80 London Road | London | SE1 6LH
T. 0207 972 2487
E. [email address]
W. www.hra.nhs.uk

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Dear FOI, Dear Stephen Tebbutt,

thank you very much for sharing this data. Please rest assured that I will use it responsibly.

Yours sincerely,

Till Bruckner

FOI, HRA (HEALTH RESEARCH AUTHORITY),

1 Attachment

Dear Till,

Freedom of Information (FOI) Act request

Further to the acknowledgement email sent to you dated 24 May please find
attached HRA response. 

Kind regards,

Freedom of Information

Health Research Authority

HRA | Skipton House, 80 London Road | London | SE1 6LH

T. 0207 972 2487

E. [1][email address]

W. [2]www.hra.nhs.uk

Our latest guidance on how the upcoming GDPR affects health research is
[3]now live

Sign up to receive our newsletter [4]HRA Latest

show quoted sections