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

Sarai Keestra made this Freedom of Information request to London School of Hygiene and Tropical Medicine

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

The request was successful.

Dear London School of Hygiene and Tropical Medicine,

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

LSHTM Servicedesk, London School of Hygiene and Tropical Medicine

LSHTM ServiceDesk
London School of Hygiene & Tropical Medicine

Re: Freedom of Information request - Clinical Trial Transparency (for UAEM
Global He

Thank you for your request for information under the Freedom of
Information Act.  We will process your request as soon as possible and
will respond within 20 working days.

Information on how we process Freedom of Information requests is available
on the LSHTM website at :
[1]https://www.lshtm.ac.uk/aboutus/organisa...

We may need to contact you again if we require further information from
you in order to process your request.
 
We will also contact you as soon as possible if we determine that a fee
will be payable for reprographics costs (such as photocopying or printing)
or postage costs associated with your request.

Please do not hesitate to contact us by reply to this email if you have
any questions relating to your request.

Regards,
Freedom of Information team

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London School of Hygiene & Tropical Medicine
Keppel Street, London WC1E 7HT UK |  [2]www.lshtm.ac.uk

 

References

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1. https://www.lshtm.ac.uk/aboutus/organisa...
2. http://www.lshtm.ac.uk/

Dear London School of Hygiene and Tropical Medicine,

I would like to remind you that my original FOI request is by now overdue by circa ten days. 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.

Thank you very much for the effort.
Yours faithfully,

Sarai Keestra

LSHTM Servicedesk, London School of Hygiene and Tropical Medicine

LSHTM ServiceDesk
London School of Hygiene & Tropical Medicine

Re: Re: Freedom of Information request - Clinical Trial Transparency (for
UAEM Globa

Thank you for your request for information under the Freedom of
Information Act.  We will process your request as soon as possible and
will respond within 20 working days.

Information on how we process Freedom of Information requests is available
on the LSHTM website at :
[1]https://www.lshtm.ac.uk/aboutus/organisa...

We may need to contact you again if we require further information from
you in order to process your request.
 
We will also contact you as soon as possible if we determine that a fee
will be payable for reprographics costs (such as photocopying or printing)
or postage costs associated with your request.

Please do not hesitate to contact us by reply to this email if you have
any questions relating to your request.

Regards,
Freedom of Information team

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London School of Hygiene & Tropical Medicine
Keppel Street, London WC1E 7HT UK |  [2]www.lshtm.ac.uk

 

References

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1. https://www.lshtm.ac.uk/aboutus/organisa...
2. http://www.lshtm.ac.uk/

LSHTM Servicedesk, London School of Hygiene and Tropical Medicine

1 Attachment

LSHTM ServiceDesk
London School of Hygiene & Tropical Medicine

Your request Freedom of Information request - Clinical Trial Transparency
(for UAEM Global He has now been completed.

Dear Ms Keestra, 

I write to provide the following response to your Freedom of information
act Request:

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.  
Yes, SOP attached as all SOPs are on the intranet/SharePoint page and not
accessible to the public. 

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.  
Yes, detailed within the attached SOP

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.  
The SOP background provides details on the selective reporting of
outcomes, but silent outcome switching is not specifically detailed. 

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.  
Yes, we are currently conducting an audit of the three registries used
within LSHTM (clinicaltrials.gov, PACTR and ISRCTN) to check for results. 
There is no document to detail this as the project stems from a discussion
with the team member assigned the task. 

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, the audit is in progress and will be reported to the Research
Governance Committee.

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Secretary
London School of Hygiene & Tropical Medicine
Keppel Street
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WC1E 7HT
Email: [London School of Hygiene and Tropical Medicine request email]
 
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Please do not hesitate to contact [London School of Hygiene and Tropical Medicine request email] if you have any
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Yours sincerely
 
Freedom of Information Team

LSHTM ServiceDesk
[1]servicedesk.lshtm.ac.uk

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London School of Hygiene & Tropical Medicine
Keppel Street, London WC1E 7HT UK | +44 (0)20 7636 8636 |
[2]www.lshtm.ac.uk

References

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