Clinical trial transparency (for UAEM Global Health Ranking)

The request was successful.

Dear University College London,

Q1. Does the university have publicly available policies and/or SOPs that require its staff to follow global best practices in clinical trial registration and registry entry maintenance?

Q2. Does the university have publicly available policies and/or SOPs that commit it to following global best practices in clinical trial summary results posting?

Q3. Has the university within the last 12 months made public an internal audit of trial registration and/or summary results posting performance? If yes, please share a link to that document.

Q4. Does the university have time-specific plans to retrospectively post missing summary results for university-sponsored clinical trials completed in the past? If yes, please share a link to that document. If the document is not online, please provide a copy of the document.

Q5. Does the university have a publicly available policy that prohibits its staff from undeclared ‘outcome switching’, HARKing, p-hacking and/or similar (mal)practices when they report clinical trial outcomes?

This FOI request is being filed on behalf of UAEM-UK and TranspariMED.

Please note that the answers to these questions will be used to determine the university’s score in the forthcoming Global Health Ranking of leading UK universities by Universities Allied for Essential Medicines (UAEM) UK.

We encourage you to read this background briefing before compiling your response:
https://www.scribd.com/document/38281405...

Note: Your university recently responded to a questionnaire sent by UAEM that covered many (though not all) of the same questions. Sadly, the majority of UK universities were less responsive than your institution. Therefore, to ensure methodological consistency, we are now forced to file FOI requests with all universities to obtain this information. We hope that the prior response to the UAEM questionnaire, which has presumably been kept on file by the university, will enable you to rapidly respond to the questions above. Please accept our apologies for the inconvenience.

Thank you very much for your time, best wishes,

Till Bruckner / TranspariMED

Finance.FOI Requests, University College London

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Data Protection & FOI
Legal Services
UCL

Finance.FOI Requests, University College London

Dear Mr Bruckner,

Thank you for your below request for information.

I note in your below e-mail that you said that UCL had recently responded to a questionnaire sent by UAEM, can you please therefore clarify which questions you now want us to respond to?

I look forward to hearing from you.

Kind regards,

Mehwish Sultan
Data Protection and Freedom of Information Adviser
University College London
Legal Services, Finance and Business Affairs
Internal address: 6th Floor, 1-19 Torrington Place, London, WC1E 7HB
E: [email address] Data Protection: [email address] FOI: [UCL request email].
Telephone: +44 (0)203 108 7862 (internal 57862)

show quoted sections

Dear Mehwish Sultan,

thank you for your rapid response.

Please reply to all FOI questions in full. We require this for methodological consistency, e.g. it will ensure that we have snapshots of all university policies obtained within exactly the same time window. In addition, a response on this platform will enable third parties (independent researchers) to also access your response and independently validate our ratings.

Yours sincerely,

Till Bruckner

Finance.FOI Requests, University College London

9 Attachments

Dear Mr Bruckner,

 

We have completed the compilation of information in response to your
request.

 

We can confirm that we do hold the information of the description
specified in your request and this information has been provided below and
attached.

 

Q1) Does the university have publicly available policies and/or SOPs that
require its staff to follow global best practices in clinical trial
registration and registry entry maintenance?

 

A1) UCL has a publicly available website for research which lists policies
related to research integrity within the institution:
[1]http://www.ucl.ac.uk/research.

 

For policy encompassing sponsored clinical research the UCL Joint Research
Office (JRO) website provides a link to researcher to the specific
Clinical Trials Unit which is delegated to approve sponsorship and manage
the clinical research. This website is currently being updated however JRO
does have a number of policies regarding clinical trials registration and
maintenance. The process in mandated in our system via a number of SOPs
and templates; some of which will be available once the new website is
live:
[2]http://www.ucl.ac.uk/jro/resources-templ...
Some examples of where this is mandated:

 

·       UCL SOP for sponsorship

·       End of trial SOP for Investigators, for uploading results onto
EudraCT

·       UCL protocol template provides a section for the EudraCT, ISRCTN
or Clinicaltrials.gov reference no. which must be completed.

·       The JRO has an investigator guide for how to set up an account on
clinicaltrials.gov

·       The SOP for initiation of a CTIMP refers to completion of an open
to recruitment checklist which again mandates placing the trial on a
publically available website.

·        The Sponsorship approval letter refers placing the trial on a
publically available website

 

All Clinical trials of Investigational Medicinal Products require CTA
approval from the MHRA (in the UK), as part of the approval process the
trial is given the EudraCT number and therefore UCL maintains an
Institutional ClinicalTrials.gov account to facilitate registration of UCL
sponsored CTIMPs.

 

Furthermore, as part of ethical approval process one of the conditions of
the approval is that the trial is that the clinical trial must be
registered on a publically accessible database within 6 weeks of
recruitment of the first participant (for medical device studies, within
the timeline determined by the current registration and publication
trees).

 

Q2) Does the university have publicly available policies and/or SOPs that
commit it to following global best practices in clinical trial summary
results posting?

 

A2) The End of Trials SOP requires that Clinical Study Report within 12
months of study completion (6 months for pediatric studies). Results are
submitted to the EudraCT database. The University also maintains an
Institutional ClinicalTrials.gov account  to facilitate publication of
results.

 

Q3) Has the university within the last 12 months made public an internal
audit of trial registration and/or summary results posting performance? If
yes, please share a link to that document.

 

A3) No.

 

Q4) Does the university have time-specific plans to retrospectively post
missing summary results for university-sponsored clinical trials completed
in the past? If yes, please share a link to that document. If the document
is not online, please provide a copy of the document.  

 

A4) In 2015, the JRO prepared a list of all trials which needed to
retrospectively add their end of study reports onto the EudraCT database.
This was completed and since then our systems ensures that all end of
summary reports are submitted.  Each CTU within UCL will have their own
mechanisms to ensure the information is updated.

 

Q5) Does the university have a publicly available policy that prohibits
its staff from undeclared ‘outcome switching’, HARKing, p-hacking and/or
similar (mal)practices when they report clinical trial outcomes?

 

A5) No.

 

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Vice Provost Operations

University College London

1-19 Torrington Place

London WC1E 7HB

 

Please note, complaints and requests for internal review received more
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01625 545700

[4]www.ico.org.uk

[5][email address]

 

Kind regards,

 

Mehwish Sultan

Data Protection and Freedom of Information Adviser

University College London

Legal Services, Finance and Business Affairs

Internal address: 6th Floor, 1-19 Torrington Place, London, WC1E 7HB

E: [6][email address] Data Protection: [7][email address]
FOI: [8][UCL request email].

Telephone: +44 (0)203 108 7862 (internal 57862)

 

References

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