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

Sarai Keestra made this Freedom of Information request to University of Southampton

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was successful.

Dear University of Southampton,

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

Support, University of Southampton

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[1]University of Southampton

Dear Sarai Keestra,

Freedom of Information Act 2000

Date of request: 20-06-2020 09:31:53 BST
Due date: 18-07-2020 00:00:00 BST
Ref: RITM0299017

Acknowledgement of request for information

Thank you for your request for information dated 20-06-2020 09:31:53 BST,
a copy of which is appended hereto for your ease of reference.

The University will endeavour to respond as soon as practicable and in any
event by 18-07-2020 00:00:00 BST. The reference for your request is
[2]RITM0299017: please quote this reference in any future correspondence
regarding this request.

Requested information:

Dear University of Southampton,

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://eur03.safelinks.protection.outlo...

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://eur03.safelinks.protection.outlo...

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://eur03.safelinks.protection.outlo...

Yours faithfully,

Sarai Keestra

Yours sincerely,

Freedom of Information Office

email: [University of Southampton request email]

 
Ref:MSG10417635

References

Visible links
2. https://sotonproduction.service-now.com/...

Support, University of Southampton

2 Attachments

  • Attachment

    southampton university logo white padded.png

    7K Download

  • Attachment

    foi signature.png

    2K Download

 

[1]University of Southampton

 

Dear Sarai Keestra,

Freedom of Information Act 2000

Request for information: response

Date of request: 20-06-2020 09:31:53 BST
Due date: 18-07-2020 00:00:00 BST
Ref: RITM0299017

We refer to your request for information dated 20-06-2020 09:31:53 BST.

Further to your request for information under the Freedom of Information
Act 2000 (the “Act”)

Please find below your question, with the University’s corresponding
response.

In accordance with [2]section 1(a) of the Act, we confirm that the
University holds information of the description specified in your request.

The answers to your questions are as follows:

Question:

Dear University of Southampton,

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:
[3]https://eur03.safelinks.protection.outlo...

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.”
[4]https://eur03.safelinks.protection.outlo...

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:
[5]https://eur03.safelinks.protection.outlo...

Yours faithfully,

Sarai Keestra

 

Answer:

The answer to your request can be found [6]here

 

If you do not feel that we have dealt with your request in accordance with
the requirements of [7]Part I of the Act, you may request a review. Your
request for a review should specify in what respect you consider that the
requirements of [8]Part I have not been met. Please address your request
to the Chief Operating Officer at the following address:
[9][University of Southampton request email].

In accordance with section 5.3 of the [10]Code of Practice, a request for
a review must sent within 40 working days of the date of this email. The
University is not obliged to accept any requests for a review beyond 40
working days.

We will endeavour to respond to your request for a review within 20
working days of receipt.

The Information Commissioner is responsible for enforcing rights of access
to information and the operation of the publication scheme. You may apply
to the Information Commissioner in writing (FOI/EIR Complaints Resolution,
Information Commissioner's Office, Wycliffe House, Water Lane, Wilmslow,
Cheshire SK9 5AF) or [11]electronically for a decision whether, in any
specified respect, your request for information has been dealt with by the
University in accordance with the requirements of [12]Part I of the Act.
The Information Commissioner will not normally take action unless they are
satisfied that the University's review procedure has been exhausted.

 

Yours sincerely,

Freedom of Information Office

email: [University of Southampton request email]

 

 
Ref:MSG10497859

References

Visible links
2. mailto:http//www.legislation.gov.uk/ukpga/2000/36/section/1
3. https://eur03.safelinks.protection.outlo...
4. https://eur03.safelinks.protection.outlo...
5. https://eur03.safelinks.protection.outlo...
6. here
https://www.southampton.ac.uk/~assets/do...
7. http://www.legislation.gov.uk/ukpga/2000...
8. http://www.legislation.gov.uk/ukpga/2000...
9. mailto:[University of Southampton request email]?subject=Request%20for%20Review%20-%20Request%20For%20Information&body=RITM0125537%0A%0APlease%20specify%20in%20what%20respect%20you%20consider%20that%20the%20requirements%20of%20Part%201%20of%20the%20Freedom%20of%20Information%20Act%20have%20not%20been%20met%3A%0A%0A
10. https://www.gov.uk/government/publicatio...
11. http://www.ico.org.uk/concerns/
12. http://www.legislation.gov.uk/ukpga/2000...

Dear University of Southampton,

I am contacting you regarding my recent FOI request filed the 20th of June which concerns clinical trial registration and reporting policies. This request has not been answered. In your reply on the 6th of July you say "The answer to your request can be found [6]here" however number 6 in the footnotes only says the word "here" but there is no response attached. I would appreciate a reply to my request as soon as possible, preferably by the 7th of August the latest.

Yours faithfully,

Sarai Keestra

Support, University of Southampton

3 Attachments

 

[1]University of Southampton

 

Dear Sarai Keestra,

Freedom of Information Act 2000

Request for information: response

Date of request: 03-08-2020 08:49:12 BST
Due date: 01-09-2020 08:49:12 BST
Ref: RITM0307430

 

We refer to your request for information dated 20-06-2020 09:31:53 BST.

Further to your e-mail received on 3 August 2020, it is uncertain to
determine why you cannot access the hyperlink to the response. 

A link has therefore been created again in the answer below.

You may want to try to right-click on the hyperlink `here` in the answer
and select open in a new tab. To assist further, in this instance we have
also attached the response for ease of reference.

 

If you experience any more difficulties in accessing the response please
do not hesitate to contact us.

 

Please find below your question, with the University’s corresponding
response.

In accordance with [2]section 1(a) of the Act, we confirm that the
University holds information of the description specified in your request.

The answers to your questions are as follows:

Question:

Dear University of Southampton,

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: [3]https://eur03.safelinks.protection.outlo...

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.”
[4]https://eur03.safelinks.protection.outlo...

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: [5]https://eur03.safelinks.protection.outlo...

Yours faithfully,

Sarai Keestra

 

Answer:

The answer to your request can be found [6]here

 

If you do not feel that we have dealt with your request in accordance with
the requirements of [7]Part I of the Act, you may request a review. Your
request for a review should specify in what respect you consider that the
requirements of [8]Part I have not been met. Please address your request
to the Chief Operating Officer at the following
address: [9][University of Southampton request email].

In accordance with section 5.3 of the [10]Code of Practice, a request for
a review must sent within 40 working days of the date of this email. The
University is not obliged to accept any requests for a review beyond 40
working days.

We will endeavour to respond to your request for a review within 20
working days of receipt.

The Information Commissioner is responsible for enforcing rights of access
to information and the operation of the publication scheme. You may apply
to the Information Commissioner in writing (FOI/EIR Complaints Resolution,
Information Commissioner's Office, Wycliffe House, Water Lane, Wilmslow,
Cheshire SK9 5AF) or [11]electronically for a decision whether, in any
specified respect, your request for information has been dealt with by the
University in accordance with the requirements of [12]Part I of the Act.
The Information Commissioner will not normally take action unless they are
satisfied that the University's review procedure has been exhausted.

 

Yours sincerely,

Freedom of Information Office

email: [University of Southampton request email]

 
Ref:MSG10659618

References

Visible links
2. mailto:http//www.legislation.gov.uk/ukpga/2000/36/section/1
3. https://eur03.safelinks.protection.outlo...
4. https://eur03.safelinks.protection.outlo...
5. https://eur03.safelinks.protection.outlo...
6. here
https://www.southampton.ac.uk/~assets/do...
7. http://www.legislation.gov.uk/ukpga/2000...
8. http://www.legislation.gov.uk/ukpga/2000...
9. mailto:[University of Southampton request email]?subject=Request%20for%20Review%20-%20Request%20For%20Information&body=RITM0125537Please%20specify%20in%20what%20respect%20you%20consider%20that%20the%20requirements%20of%20Part%201%20of%20the%20Freedom%20of%20Information%20Act%20have%20not%20been%20met%3A
10. https://www.gov.uk/government/publicatio...
11. http://www.ico.org.uk/concerns/
12. http://www.legislation.gov.uk/ukpga/2000...

Taiwan_hf_machine,

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University of Southampton

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Taiwan_hf_machine,

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University of Southampton

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Dear University of Southampton,

I just want to alert you that since sending a FOI to your university I have received advertisement from a company called "Taiwan hf machine" in both English and Chinese. You can find a history of the conversation with your university here: https://www.whatdotheyknow.com/request/c... as well as the spam email I have been receiving. This has not happened to me before with other universities that I have contacted with FOI requests. I just wanted to alert you of this in case it has happened for other people as well after contacting you with a FOI request. Have a good Christmas!

Yours faithfully,

Sarai Keestra