Dear University of Oxford,
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.”
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”.
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.
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
Representative of UAEM UK
Dear Ms Rodgers
Thank you for your Freedom of Information request.
Subject to any clarification required, the University will aim to reply to your request within the statutory deadline of 20 working days, starting from the day after receipt of your request. Please note that several University departments are under considerable strain because of pressures from the Covid-19 crisis. If your request involves one of these departments, we may find it difficult to respond by the statutory deadline. If we anticipate a delay, we will write to you nearer to the deadline to inform you of the position.
Information Compliance Team
Vice Chancellor’s and Registrar’s Office | University of Oxford
University Offices | Wellington Square | Oxford | OX1 2JD
Dear Florence Rodgers,
Our reference: FOI/20200620/1
Please find attached the University's response to your request.
Information Compliance Team
Vice Chancellor’s and Registrar’s
cid:image013.jpg@01CD755D.56992DA0 Office | University of Oxford
University Offices, Wellington
Square, Oxford, OX1 2JD
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