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

The request was successful.

Florence Rodgers

Dear University of Edinburgh,

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,
Florence Rodgers
Representative of UAEM UK

Records Management, University of Edinburgh

Thank you for your email. The University’s working arrangements are
affected by the Coronavirus outbreak but we will respond to your enquiry
as soon as possible.

 

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within statutory timescales. The [1]Scottish Information Commissioner’s
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[3]The University of Edinburgh's request privacy notice, which describes
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request, is published on the University website.

 

The University of Edinburgh is a charitable body, registered in Scotland,
with registration number SC005336.

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Records Management, University of Edinburgh

Dear Ms Rodgers

Thank you for your email of 20 June 2020 requesting information about clinical trials.

As explained in our automatic reply message, the University’s working arrangements are affected by the Coronavirus outbreak. Unfortunately, I am currently unable to tell you exactly when you will receive a response to your request. However, I can confirm that it is actively being progressed and that we are making all efforts to respond to your request promptly. The Scottish Information Commissioner’s Office has issued a statement about requests during the Covid-19 pandemic which you may find helpful.

If you are unhappy with the way the University has handled your request, you do have the right to ask the University to conduct an internal review of the reasons for the delay. The Scottish Information Commissioner’s guidance about this during the Covid-19 pandemic is available on their website. If you wish to submit a review request you should write to the Records Management Section (using this email address), describing the original request, explaining your grounds for dissatisfaction, and including an address for correspondence. When the review process is complete, if you are still dissatisfied, you may use the Scottish Information Commissioner’s guidance on making an appeal to make an appeal to the Commissioner.

The University of Edinburgh's request privacy notice, which describes how we use the information you have supplied about yourself and your request, is published on the University website.

Yours sincerely

Rob Don
Information Compliance Officer
Records Management Section
The University of Edinburgh | Old College | South Bridge | Edinburgh | EH8 9YL

Telephone: 0131 651 4099
Email: [University of Edinburgh request email]
Website: http://www.ed.ac.uk/records-management

show quoted sections

Florence Rodgers

Dear Rob,

I would like to remind you that my original FOI request is overdue by at least a week now already. Because of the ongoing pandemic I do understand that delays in responding to requests can be expected. However more than ten other universities I sent the same FOI request to replied within 20 working days. I would therefore appreciate a response to my request by the 9th of August if possible.

Yours sincerely,

Florence Rodgers

Records Management, University of Edinburgh

Thank you for your email. The University’s working arrangements are
affected by the Coronavirus outbreak but we will respond to your enquiry
as soon as possible.

 

Information requests (freedom of information requests, environmental
information requests, data subject rights requests)

While we will make all efforts to respond to requests promptly, please be
aware that in some cases unfortunately we will not be able to respond
within statutory timescales. The [1]Scottish Information Commissioner’s
Office and the [2]Information Commissioner’s Office have both issued
statements about requests during the Covid-19 pandemic which you may find
helpful.

Please note that if you have only provided your first (or given) name in
the body of your email your request will not be valid.  To ensure your
request is valid and that the University is obliged to answer it, you must
provide your real name.  If you are making the request on behalf of
someone else you must provide their real name.  The Office of
the [3]Scottish Information Commissioner's guidance on this point explains
that if you do not provide your real name or the name of the person on
whose behalf you are making the request, you will lose your right to
appeal to the Commissioner should you be unhappy with the handling of your
request. The guidance also explains what constitutes a real name for the
purposes of making a request valid. Please refer to the guidance for
further details.

 

[4]The University of Edinburgh's request privacy notice, which describes
how we use the information you have supplied about yourself and your
request, is published on the University website.

 

The University of Edinburgh is a charitable body, registered in Scotland,
with registration number SC005336.

References

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1. http://www.itspublicknowledge.info/home/...
2. https://ico.org.uk/
3. http://www.itspublicknowledge.info/Law/F...
4. https://www.ed.ac.uk/records-management/...

Records Management, University of Edinburgh

1 Attachment

Dear Ms Rodgers

 

Thank you for your email of 20 June 2020 requesting information about
clinical trials.  Please accept our apologies for the delay to our
response to your request. 

 

Please find our response attached.

 

Yours sincerely

Dean McAdam

Information Compliance Officer

Records Management Section

The University of Edinburgh | Old College | South Bridge | Edinburgh | EH8
9YL

 

Email: [1][University of Edinburgh request email]

 

 

 

The University of Edinburgh is a charitable body, registered in Scotland,
with registration number SC005336.

References

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1. mailto:[University of Edinburgh request email]