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

Roedd y cais yn llwyddiannus.

Dear University of Reading,

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

IMPS, University of Reading

Dear Ms Keestra,

This is to acknowledge receipt of your request for information.

COVID19 – Notice of possible impact on requests for information

The University is doing all it can to minimise disruption and meet
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understanding would be much appreciated.

Please be advised that many staff across the University are now working
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We will do all we can to respond to your request in 20 working days from
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We would like to ask you to help us at this time by:

·         Consulting our [1]publication scheme prior to making a request –
the information may already be available. If you subsequently find the
information you have requested is already available, please notify us and
withdraw your request

·         If you are seeking information relating to COVID19 measures
taken by the University, please consult our dedicated pages [2]here

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Your request has been assigned a reference number in the subject line;
please quote this on future correspondence, thank you.

Yours sincerely,

Sinead Latham

Information Management & Policy Services (IMPS), University of Reading,
Whiteknights, Reading, RG6 6AH

www.reading.ac.uk/foia  

dangos adrannau a ddyfynnir

IMPS, University of Reading

Dear Ms Keestra,

 

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

  

We can confirm that we do hold some information of the description
specified in your request. Our responses are given below each limb of your
request below.

 

For clarity please be advised, the University of Reading has not
undertaken CTIMPS (Clinical Trials of Investigatory Medicinal Products).
However, we have answered the questions below using the definition
provided in web-document linked to in your request and as set out by WHO.

 

We are required to include details of our complaints procedures, including
your rights to apply to the Information Commissioner.  The procedure is
detailed in our Freedom of Information and Environmental Information
Regulations policy on the web at
[1]www.reading.ac.uk/freedom-of-information-policy

 

If we are unable to resolve any complaint, you can complain to the
Information Commissioner, the independent body who oversees the access to
information regimes: [2]https://ico.org.uk/make-a-complaint/ 

 

 

Yours sincerely, 

 

Sinead Latham

Information Compliance Officer

 

Information Management & Policy Services (IMPS), University of Reading,
Whiteknights, Reading, RG6 6AH

[3][University of Reading request email]    t: +44 (0)118 378 8981   
[4]www.reading.ac.uk/foia

dangos adrannau a ddyfynnir