University clinical trial reporting systems and plans

The request was successful.

Dear Sir/Madam,

I am filing this freedom of information request on behalf of TranspariMED.

Evidence recently submitted to parliament indicates that the university failed to upload any due clinical trial results onto the European trial registry EudraCT between February and October 2019:
http://data.parliament.uk/writtenevidenc...

Q1. Has the university put into place policies, systems and processes that ensure that in future, every clinical trial sponsored by the university will post its summary results on every WHO primary trial registry (including Clinicaltrials.gov and ISRCTN) where it was originally registered within 12 months of trial completion? If yes, please state the month and year in which these were put into place. If no, if applicable, please state the month and year by which these are expected to be in place.

Q2. Has the university conducted a registry-data based audit of all clinical trials it has sponsored in the past that are listed on trial registries, including all interventional clinical trials listed on the registries EudraCT, ISRCTN, and Clinicaltrials.gov, to identify those trials that have never reported their results (i.e. neither on a registry nor on in a peer-reviewed academic journal)? If yes, please state the month and year in which the audit was completed. If no, if applicable, please state the month and year by which such an audit is expected to be completed.

Q3. Has the university developed a plan for retrospectively reporting the results of past trials that have remained unreported (i.e. reported neither on a registry nor on in a peer-reviewed academic journal)? If yes, please state the month and year the plan was adopted, and the month and year by which the process of retrospective results posting is expected to be completed. If no, if applicable, please the state the month and year by which such a plan is expected to be adopted.

Q4. By when does the university plan to have uploaded all due clinical trial results onto EudraCT?

Definitions:

For the purpose of this FOI request, a clinical trial is defined as per the WHO definition:
“[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, behavioural treatments, process-of-care changes, preventive care, etc.”

Note:

A summary of the recent parliamentary session on clinical trial transparency, and a collection of useful tools for trial sponsors, can be found on the TranspariMED website.

Thank you for your time, best wishes,

Till Bruckner

FOI Requests, Aston University

1 Attachment

Dear Mr Bruckner  

Our ref: FOI/1920/096

Thank you for your email of 9 November 2019. Your request will be dealt
with under the terms of the Freedom of Information Act 2000 and will be
answered within twenty working days of receipt. We will endeavour to
provide the information as early as possible.

If you have any queries about this request please do not hesitate to
contact us, quoting the reference number above.

Kind regards.

Yours sincerely,

Alice Mineyko

 

Alice Mineyko
Counsel
[1]http://static.aston.ac.uk/emails/sigs/au...
Office of the General Counsel
Birmingham, B4 7ET, UK
aston.ac.uk

 

The contents of this email and any attachments may be privileged and are
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From: Till Bruckner [mailto:[FOI #618625 email]]
Sent: 09 November 2019 18:13
To: FOI Requests <[Aston University request email]>
Subject: Freedom of Information request - University clinical trial
reporting systems and plans

 

Dear Sir/Madam,

 

I am filing this freedom of information request on behalf of TranspariMED.

 

Evidence recently submitted to parliament indicates that the university
failed to upload any due clinical trial results onto the European trial
registry EudraCT between February and October 2019:

[2]https://eur02.safelinks.protection.outlo...

 

Q1. Has the university put into place policies, systems and processes that
ensure that in future, every clinical trial sponsored by the university
will post its summary results on every WHO primary trial registry
(including Clinicaltrials.gov and ISRCTN) where it was originally
registered within 12 months of trial completion? If yes, please state the
month and year in which these were put into place. If no, if applicable,
please state the month and year by which these are expected to be in
place.

 

Q2. Has the university conducted a registry-data based audit of all
clinical trials it has sponsored in the past that are listed on trial
registries, including all interventional clinical trials listed on the
registries EudraCT, ISRCTN, and Clinicaltrials.gov, to identify those
trials that have never reported their results (i.e. neither on a registry
nor on in a peer-reviewed academic journal)? If yes, please state the
month and year in which the audit was completed. If no, if applicable,
please state the month and year by which such an audit is expected to be
completed.

 

Q3. Has the university developed a plan for retrospectively reporting the
results of past trials that have remained unreported (i.e. reported
neither on a registry nor on in a peer-reviewed academic journal)? If yes,
please state the month and year the plan was adopted, and the month and
year by which the process of retrospective results posting is expected to
be completed. If no, if applicable, please the state the month and year by
which such a plan is expected to be adopted.

 

Q4. By when does the university plan to have uploaded all due clinical
trial results onto EudraCT?

 

Definitions:

 

For the purpose of this FOI request, a clinical trial is defined as per
the WHO definition:

“[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,
behavioural treatments, process-of-care changes, preventive care, etc.”

 

Note:

 

A summary of the recent parliamentary session on clinical trial
transparency, and a collection of useful tools for trial sponsors, can be
found on the TranspariMED website.

 

Thank you for your time, best wishes,

 

Till Bruckner

 

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FOI Requests, Aston University

2 Attachments

Dear Mr Bruckner

 

Please find attached our response to your request for information.

 

Kind regards.

 

Yours sincerely,

 

Alice Mineyko

 

Alice Mineyko
Counsel
[1]http://static.aston.ac.uk/emails/sigs/au...
Office of the General Counsel
Birmingham, B4 7ET, UK
aston.ac.uk

 

The contents of this email and any attachments may be privileged and are
confidential.  It may not be disclosed to or used by anyone other than the
addressee, nor copied in any way.  If received in error, please notify the
sender and then delete it from your system.  Aston University does not
accept service by email.

 

From: Till Bruckner [mailto:[FOI #618625 email]]
Sent: 09 November 2019 18:13
To: FOI Requests <[Aston University request email]>
Subject: Freedom of Information request - University clinical trial
reporting systems and plans

 

Dear Sir/Madam,

 

I am filing this freedom of information request on behalf of TranspariMED.

 

Evidence recently submitted to parliament indicates that the university
failed to upload any due clinical trial results onto the European trial
registry EudraCT between February and October 2019:

[2]https://eur02.safelinks.protection.outlo...

 

Q1. Has the university put into place policies, systems and processes that
ensure that in future, every clinical trial sponsored by the university
will post its summary results on every WHO primary trial registry
(including Clinicaltrials.gov and ISRCTN) where it was originally
registered within 12 months of trial completion? If yes, please state the
month and year in which these were put into place. If no, if applicable,
please state the month and year by which these are expected to be in
place.

 

Q2. Has the university conducted a registry-data based audit of all
clinical trials it has sponsored in the past that are listed on trial
registries, including all interventional clinical trials listed on the
registries EudraCT, ISRCTN, and Clinicaltrials.gov, to identify those
trials that have never reported their results (i.e. neither on a registry
nor on in a peer-reviewed academic journal)? If yes, please state the
month and year in which the audit was completed. If no, if applicable,
please state the month and year by which such an audit is expected to be
completed.

 

Q3. Has the university developed a plan for retrospectively reporting the
results of past trials that have remained unreported (i.e. reported
neither on a registry nor on in a peer-reviewed academic journal)? If yes,
please state the month and year the plan was adopted, and the month and
year by which the process of retrospective results posting is expected to
be completed. If no, if applicable, please the state the month and year by
which such a plan is expected to be adopted.

 

Q4. By when does the university plan to have uploaded all due clinical
trial results onto EudraCT?

 

Definitions:

 

For the purpose of this FOI request, a clinical trial is defined as per
the WHO definition:

“[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,
behavioural treatments, process-of-care changes, preventive care, etc.”

 

Note:

 

A summary of the recent parliamentary session on clinical trial
transparency, and a collection of useful tools for trial sponsors, can be
found on the TranspariMED website.

 

Thank you for your time, best wishes,

 

Till Bruckner

 

-------------------------------------------------------------------

 

Please use this email address for all replies to this request:

[3][FOI #618625 email]

 

Is [4][Aston University request email] the wrong address for Freedom of
Information requests to Aston University? If so, please contact us using
this form:

[5]https://eur02.safelinks.protection.outlo...

 

Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:

[6]https://eur02.safelinks.protection.outlo...

 

For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:

[7]https://eur02.safelinks.protection.outlo...

 

Please note that in some cases publication of requests and responses will
be delayed.

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

 

-------------------------------------------------------------------

References

Visible links
2. https://eur02.safelinks.protection.outlo...
3. mailto:[FOI #618625 email]
4. mailto:[Aston University request email]
5. https://eur02.safelinks.protection.outlo...
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7. https://eur02.safelinks.protection.outlo...