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

Florence Rodgers made this Freedom of Information request to University of Exeter

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The request was successful.

Florence Rodgers

Dear University of Exeter,

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

InformationGovernance mailbox, University of Exeter

Dear Florence,

Thank you for your request under the information Act of 2000. Your reference number is FOI20-230

Due to the exceptional circumstances caused by current global events there may be some delay in responding to your information request. Following the guidance from the ICO the Information Governance Team continue to work to the timelines set out in law however while the University transitions to new working practices there may be some delays to the responses we receive from data owners and other colleagues across the organisation.

To avoid any of these delays we would urge you to check public data sources including the University website, HESA, UCAS and the Research Councils. Please also ensure that your request is clearly stated so that we can ensure we are directing requests to the most appropriate areas of the business.

The data you provide to allow us to process your request is collected so that you are able to exercise your lawful rights under the Freedom of Information Act. Your personal data will be held by the Information Governance Office and shared with relevant staff as necessary.

Once a request has been completed, the relevant data will be held by the Information Governance Office for three years in line with ICO guidance, this is to ensure the University has fully carried out its requirements under the legislation.

For further information on how we process your personal data, please see: http://www.exeter.ac.uk/dataprotection/

The University should respond to your FOI request as soon as possible and no later than twenty working days after the date of receipt of the request. Should The University be required to undertake a public interest test relating to the potential application of a qualified exemption we may extend the time frame by up to twenty additional days. Please be aware that our response time takes into account the workloads of the Information Governance Office and relevant data owners and will therefore not always correlate with the complexity of the request. Should The University seek clarification any resulting time spent awaiting communication will not be counted against that time limit.

Regards,

Information Governance Officer

University of Exeter
www.exeter.ac.uk
Lafrowda House, St. German’s Road, Exeter, EX4 6TL

This email and any attachment may contain information that is confidential, privileged, or subject to copyright, and which may be exempt from disclosure under applicable legislation. It is intended for the addressee only. If you received this message in error, please let me know and delete the email and any attachments immediately. The University will not accept responsibility for the accuracy/completeness of this email and its attachments.

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InformationGovernance mailbox, University of Exeter

1 Attachment

Dear Florence,

Please find the University's response to your Freedom of Information Request attached.

Kind regards,
Information Governance Officer

University of Exeter
http://www.exeter.ac.uk/foi/summary/
Lafrowda House, St. German’s Road, Exeter, EX4 6TL

This email and any attachment may contain information that is confidential, privileged, or subject to copyright, and which may be exempt from disclosure under applicable legislation. It is intended for the addressee only. If you received this message in error, please let me know and delete the email and any attachments immediately. The University will not accept responsibility for the accuracy/completeness of this email and its attachments.

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Florence Rodgers

Dear University of Exeter,

Thank you for you response and for linking the policies on your website.
Would you be able to clarify if any of these have changed since the 30th April 2018 as I cannot find this information on the web page. Thank you for your help.

Yours sincerely,

Florence Rodgers

InformationGovernance mailbox, University of Exeter

Good Morning Florence,

Apologies for the delay in responding. The University can confirm the clinical trials transparency policy has not changed. The Code of Good Practice in the Conduct of Research is currently under review.

Kind regards

Information Governance Officer

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