Clinical Trial Transparency (for UAEM Global Health Ranking) Update Since 2018

Sarai Keestra made this Freedom of Information request to University College London

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

The request was successful.

Dear University College London,

This FOI is being filed in order to allow Universities Allied for Essential Medicines UK (UAEM-UK) to gain insight into current clinical trial transparency policies and practices at selected UK universities, with the goal of informing the development of UAEM-UK’s forthcoming 2015-2020 Global Health Ranking of UK universities. Please find a background briefing to the project here: https://tinyurl.com/y9prgqcd

We sent a similar request in 2018 and in the request we are interested in changes in policies during this time period only (i.e. between 30th of April 2018 and 31st of May 2020).

The term “clinical trial” in the questions below refers to clinical trials as defined by the World Health Organization:
“[A] clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.”
https://www.who.int/health-topics/clinic...

The term “silent outcome switching” in Q3 below is defined as “adding, suppressing or switching a clinical trial’s outcome measures (compared to the pre-defined outcome measures set out at the beginning of the trial in the trial’s protocol and/or registry entry) when reporting a trial’s outcome in an academic journal without explicitly flagging such post hoc changes within the journal article”.

START FOI
Please respond to the following questions and provide us with electronic copies of the relevant documents:

Q1: Since the 30th of April 2018 has the university changed or created policy/policies regarding registration of clinical trials on clinical trial registries, by the university itself and/or by university staff? If yes, please provide a link to the policy/policies. If the policy/policies are not publicly accessible online, please provide an electronic copy of the policy/policies.

Q2: Since the 30th of April 2018 has the university changed or created policy/policies that require the posting of the summary results of clinical trials on clinical trial registries, by the university itself and/or by university staff? If yes, please provide a link to the policy/policies. If the policy/policies are not publicly accessible online, please provide an electronic copy of the policy/policies.

Q3: Since the 30th of April 2018 has the university changed or created policy/policies that prohibit its staff from silent outcome switching when they report clinical trial outcomes in academic journals? If yes, please provide a link to the policy/policies. If the policy/policies are not publicly accessible online, please provide an electronic copy of the policy/policies.

Q4: Does the university have time-specific plans to retrospectively post missing summary results onto trial registries 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: Since the start of 2018 has the university made public an internal audit of trial registration and/or summary results posting performance? If yes, please provide a link to that document.

END FOI

Thank you for taking the time to address this and we look forward to your response. If you are expecting any delays due to the COVID-19 pandemic please do let us know. We would like to refer you to BIH QUEST’s recently published clinical trial reporting manual to improve clinical trial transparency at your university: https://tinyurl.com/y8p6z5bn

Yours faithfully,

Sarai Keestra

Finance.FOI Requests, University College London

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References

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1. https://www.ucl.ac.uk/legal-services/pri...

Finance.FOI Requests, University College London

Dear Ms Keestra,

 

Apologies for the delay in responding to your request for information.

 

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

 

We can confirm that we do hold information of the description specified in
your request and this information, where it is not exempt, is provided
below.

 

Your request and our response

 

Q1: Since the 30th of April 2018 has the university changed or created
policy/policies regarding registration of clinical trials on clinical
trial registries, by the university itself and/or by university staff? If
yes, please provide a link to the policy/policies. If the policy/policies
are not publicly accessible online, please provide an electronic copy of
the policy/policies.

 

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 policies encompassing sponsored
clinical research the UCL Joint Research Office (JRO) website provides a
link to the specific Clinical Trials Unit which, is delegated to approve
sponsorship and manage the clinical research. This website is currently
being updated however, the JRO does have a number of policies regarding
clinical trials registration and maintenance. The process is mandated in
our system via a number of standard operating procedures (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 are as follows:

 

•                     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 number 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 Clinical Trials of
Investigational Medicinal Products (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 CTIMPs 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 the ethical approval process one of the conditions
of the approval is that the clinical trial must be registered on a
publically accessible database within six weeks of recruitment of the
first participant (for medical device studies, this should be within the
timeline determined by the current registration and publication trees).

 

UCL is currently reviewing its processes on transparency in research. For
studies on EudraCT, we have tightened our processes and have 100%
reporting, we are now mirroring the same system for Clinicaltrials.gov.

 

Q2: Since the 30th of April 2018 has the university changed or created
policy/policies that require the posting of the summary results of
clinical trials on clinical trial registries, by the university itself
and/or by university staff? If yes, please provide a link to the
policy/policies. If the policy/policies are not publicly accessible
online, please provide an electronic copy of the policy/policies.

 

As per the clinical trials regulations, CTIMPs have to report their
results within one year of declaration of the end of a trial onto EudraCT.
Our SOPs already cover EudraCT reporting but, are currently being updated
to include Clinical trials.gov and any other registry a trial may have
been registered with. These updated SOPs will be published on the JRO
website by the end of 2020 and have therefore been withheld under Section
22 of the Freedom of Information Act 2000 (please see below for further
explanation).

 

We are also currently considering how we can ensure registration and
reporting of non-regulated UCL clinical trials, such as those that take
place outside of hospitals or abroad.

Q3: Since the 30th of April 2018 has the university changed or created
policy/policies that prohibit its staff from silent outcome switching when
they report clinical trial outcomes in academic journals? If yes, please
provide a link to the policy/policies. If the policy/policies are not
publicly accessible online, please provide an electronic copy of the
policy/policies.

 

For CTIMPs, we are currently reviewing our systems for data reporting. We
are currently working closely with our statisticians to tighten our
policies. These policies will be published on the JRO website by the end
of 2020 and have therefore been withheld under Section 22 of the Freedom
of Information Act 2000 (please see below for further explanation).

 

For non-CTIMP study registration and data reporting, we are working on
SOPs and reporting which will also be published on the JRO website by the
end of 2020.

 

Q4: Does the university have time-specific plans to retrospectively post
missing summary results onto trial registries 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.

 

All information is available on EudraCT
([3]https://eu.trialstracker.net/sponsor/uni...) and
here: [4]https://www.clinicaltrialsregister.eu/ct....

 

With regards to Clinicaltrials.gov, the intention is to have the missing
summary results information available by Summer 2021 published on the
following webpage: [5]https://clinicaltrials.gov/.

 

Q5: Since the start of 2018 has the university made public an internal
audit of trial registration and/or summary results posting performance? If
yes, please provide a link to that document.

 

No.

 

Section 22 of the Freedom of Information Act 2000 states:

 

“(1) Information is exempt information if—

(a) the information is held by the public authority with a view to its
publication, by the authority or any other person, at some future date
(whether determined or not),

(b) the information was already held with a view to such publication at
the time when the request for information was made, and

(c) it is reasonable in all the circumstances that the information should
be withheld from disclosure until the date referred to in paragraph (a).”

 

This exemption applies to some of the information you have requested for
questions 2 and 3. This is because our intention is to publish this
information during the course of 2020. Preparing this information for
publication will require a considerable investment in terms of time and
effort but will be an important part of UCL’s wider drive towards
transparency. Given that there are firm plans in place for the publication
of the data in the near future, we consider it as reasonable to withhold
disclosure under the FOI regime at this current time.

 

Section 22 is a qualified exemption under the Act and so a public interest
test is required to assess where the balance of disclosure/non-disclosure
lies. Please see below for the test in full.

 

Public Interest Test

 

Factors in favour of disclosure of the requested information:

 

·         It is recognised that there is currently substantial public
interest in accessing information in relation to transparency surrounding
the reporting of clinical trials.

 

Factors against disclosure of the requested information:

 

·         The information being requested is due for publication in the
near future. Diverting attention to supplying the information for an FOI
request would disrupt the process of preparing this information for
intended publication.

·         UCL believes that, in order to meet its obligations of
transparency, it is better to be focused on publishing full and complete
information on this subject matter. Answering some of the questions for
this FOI request would lead to less complete information being released
into the public domain, and to the information not being released in a
manner which would be fully accessible to the public in the way it would
be when published on our website.

 

Outcome of public interest test:

 

·       On account of more complete information on this subject being
planned for publication in the near future, it is considered that the
public interest arguments against disclosure outweigh those for disclosure
in this instance.

 

You are free to use any information supplied for your own use, including
for non-commercial research purposes. The information may also be used for
the purposes of news reporting. However, any other type of re-use, for
example by publishing or issuing copies to the public, will require the
permission of the copyright owner.

 

If you are unhappy with our response to your request and wish to make a
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[6][email address]. Emails should include the words ‘Internal
Review’ in the subject and be marked For the Attention of the Chief
Operating Officer, alternatively you should write to:

 

Chief Operating Officer

University College London

Gower Street

London

WC1E 6BT

 

If you are not content with the outcome of the internal review, you may
apply directly to the Information Commissioner at the address given below.
You should do this within two months of our final decision. (Please note,
complaints and requests for internal review received more than two months
after the initial decision will not be handled.)

 

If you have any queries or concerns, please contact me using the details
provided in this email and including the request reference number.

 

Further information on the Freedom of Information Act is available from
the Information Commissioner’s Office:

 

Wycliffe House

Water Lane

Wilmslow

SK9 5AF

 

01625 545700

[7]www.ico.org.uk

[8][email address]

 

Kind regards,          

 

Mehwish Sultan

Data Protection and Freedom of Information Adviser

University College London

Legal Services

E: [9][email address]; Data Protection: [10][email address];
FOI: [11][UCL request email].

Office phone: +44 (0)203 108 7862 (internal extension: 57862); Mobile: +44
(0)7525285822

 

Working hours: Please note that my current working hours are Monday to
Friday 8am – 4pm.

 

References

Visible links
1. http://www.ucl.ac.uk/research
2. http://www.ucl.ac.uk/jro/resources-templ...
3. https://eu.trialstracker.net/sponsor/uni...
4. https://www.clinicaltrialsregister.eu/ct...
5. https://clinicaltrials.gov/
6. mailto:[email address]
7. http://www.ico.org.uk/
8. mailto:[email address]
9. mailto:[email address]
10. mailto:[email address]
11. mailto:[UCL request email]

Dear UCL FOI Requests Office,

Thank you very much for your comprehensive response. We would like however like a clarification on the following two points.

1. Would you please be able to to provide a PDF version of the exact SOPs that you were referring to in your request, or an individual link to each SOP you mention as asked for in our original request?
"• 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 number 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 Clinical Trials of
Investigational Medicinal Products (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."

2. Could you please specify exactly which of the SOPs you mention in response to Q1 have changed since the 30th of April 2018, or if no changes were made in the UCLs SOPs regarding the registration of clinical trials on clinical trial registries, by the university itself and/or by university staff since this date?

Thank you for clarifying your response.
Yours sincerely,

Sarai Keestra

Finance.FOI Requests, University College London

Dear Sarai,

Thank you for your e-mail.

I will look into this and will get back to you as soon as I can.

Kind regards,

Mehwish Sultan
Data Protection and Freedom of Information Adviser
University College London
Legal Services
E: [email address]; Data Protection: [email address]; FOI: [UCL request email].
Office phone: +44 (0)203 108 7862 (internal extension: 57862); Mobile: +44 (0)7525285822

Working hours: Please note that my current working hours are Monday to Friday 8am – 4pm.

show quoted sections

Finance.FOI Requests, University College London

6 Attachments

Dear Sarai,

In answer to your below request for clarification, please find attached the UCL SOPs which are available on the JRO website along with our comments below:

1. JRO Sponsorship SOP for CTIMPs: https://www.ucl.ac.uk/joint-research-off...
2. CTIMP Protocol Template: https://www.ucl.ac.uk/joint-research-off... Please note that the template is currently in revision. It does reference a EudraCT number and other registries on page 3.
3. JRO Sponsor End of Trial SOP for CTIMPs: https://www.ucl.ac.uk/joint-research-off.... We have also attached a superceded version of this SOP which was effective in August 14 and includes EudraCT reporting. The latest version has updated information on EudraCT reporting.
4. JRO SOP for Archiving: https://www.ucl.ac.uk/joint-research-off.... We have also attached an old version (V3 dated 15/05/2015) which was updated to include EudraCT reporting.
5. Attached Submission on EudraCT for results guide for Investigators date 16.09.2015
6. SOP Initiation of a CTIMP dated 08.08.2018 currently in draft and the Open to recruitment checklist (V1 dated Nov 13) which is currently under review.

Kind regards,

Mehwish Sultan
Data Protection and Freedom of Information Adviser
University College London
Legal Services
E: [email address]; Data Protection: [email address]; FOI: [UCL request email].
Office phone: +44 (0)203 108 7862 (internal extension: 57862); Mobile: +44 (0)7525285822

Working hours: Please note that my current working hours are Monday to Friday 8am – 4pm.

show quoted sections