Clinical trial transparency policies and practices
Dear University of Liverpool,
This FOI is being filed in order to allow Universities Allied for Essential Medicines UK (UAEM-UK) and TranspariMED 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 2018 Global Health Ranking of UK universities.
We encourage you to read the background briefing linked here before responding to this FOI request:
https://www.scribd.com/document/37383698...
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.”
http://www.who.int/topics/clinical_trial...
The term “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 refer to the background briefing for further information on outcome switching.
Please respond to the following three questions:
Q1: Does the university have a policy/policies that require the 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: Does the university have a 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: Does the university have a policy/policies that prohibit its staff from 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.
Thank you for your time, best wishes,
Till Bruckner (TranspariMED)
Dear Mr. Bruckner,
Thank you for your email of 14th March 2018 requesting information about clinical trial transparency. I am writing to let you know that we have received your request and will process it as soon as possible, and in any case within 20 working days of the day we received the request. You will hear back from us by 16th April 2018 at the latest.
Yours sincerely
Mrs Lesley Jackson, FOI Co-ordinator
The University of Liverpool, Foundation Building,
765 Brownlow Hill, Liverpool L69 7ZX
Email [University of Liverpool request email]
[1]Mrs Lesley Jackson Freedom of Information Co-ordinator The Foundation
Building 765 Brownlow Hill Liverpool L69 7ZX F 0151 794 3272 E
[University of Liverpool request email] www.liverpool.ac.uk
FOI/LJ
11^th April 2018
Mr. Till Bruckner
Via email: [2][FOI #471103 email]
Dear Mr. Bruckner,
Thank you for your email of 14^th March 2018 requesting information
concerning clinical trial transparency policies and practices at the
University of Liverpool. I am pleased to provide the information as set
out below:-
Q1: Does the university have a policy/policies that require the
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.
This is not detailed in a particular document, but it forms part of our
Sponsor Permission to Proceed checklist (detailed in SOP004 attached), and
we also abide by the requirements of the Health Research Authority
Research Ethics Committees that clinical trials must be registered before
REC favourable opinion begins.
Q2: Does the university have a 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.
For CTIMPs this is detailed in a SOP021 (attached), and also forms part of
our Sponsor End of Study Checklist
Q3: Does the university have a policy/policies that prohibit its staff
from 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 University requires researchers to adhere to legal frameworks, which
in this instance would require them to report according to the protocol
i.e. no unauthorised switching.
If you are not satisfied with the University’s response to your request,
you may ask the University to review it. If you wish to do this, please
write to the Freedom of Information Reviewer, Legal, Risk & Compliance,
The University of Liverpool, The Foundation Building, 765 Brownlow Hill,
Liverpool, L69 7ZX (email [3][University of Liverpool request email]), enclosing a copy of
your original request and explaining your complaint. Please include an
address for correspondence.
If you remain dissatisfied with the handling of your request, you have a
right to appeal to the Information Commissioner at:-
The Information Commissioner’s Office, Wycliffe House, Water Lane,
Wilmslow, Cheshire, SK9 5AF.
Telephone: 0303 123 1113
Website: [4]www.ico.org.uk
Yours sincerely,
Lesley Jackson
Freedom of Information Co-ordinator
Dear Lesley Jackson,
thank you very much for providing this information in a timely manner.
Yours sincerely,
Till Bruckner
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