Clinical trial reporting: prospective and retrospective

Roedd y cais yn llwyddiannus.

Dear University of Exeter,

Q1. Has the university put into place policies, systems and processes that ensure that in future, every clinical trial sponsored by the university will post its summary results on every WHO primary trial registry (including Clinicaltrials.gov) where it was originally registered within 12 months of trial completion? If yes, please state the month and year in which these were put into place. If no, if applicable, please state the month and year by which these are expected to be in place.

Q2. Has the university conducted a registry-data based audit of all clinical trials it has sponsored in the past, including all clinical trials listed on the registries EudraCT, ISRCTN, and Clinicaltrials.gov, to identify those trials that have never reported their results (i.e. neither on a registry nor on in a peer-reviewed academic journal)? If yes, please state the month and year in which the audit was completed. If no, if applicable, please state the month and year by which such an audit is expected to be completed.

Q3. Has the university developed a plan for retrospectively reporting the results of past trials that have remained unreported (i.e. reported neither on a registry nor on in a peer-reviewed academic journal)? If yes, please state the month and year the plan was adopted, and the month and year by which the process of retrospective results posting is expected to be completed. If no, if applicable, please the state the month and year by which such a plan is expected to be adopted.

Definitions:

For the purpose of this FOI request, a clinical trial is defined as per the WHO definition:
“[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, behavioural treatments, process-of-care changes, preventive care, etc.”

Context:

A January 2019 report by TranspariMED and Universities Allied for Essential Medicines (UAEM) found that many UK universities had initiated the process of uploading missing clinical trial summary results onto EudraCT. However, it remains unclear whether and to what extent universities are planning to extend these efforts to trials missing results on Clinicaltrials.gov and ISRCTN. In this context, clinical trials that have never reported their results and are thus in danger of becoming research waste are of particular concern.

Please note that TranspariMED is aware of the practical challenges UK universities face in retrospectively posting summary results onto registries. In February 2019, TranspariMED jointly with Health Action International released the report “Clinical Trials in The European Union: A Roadmap to Greater Transparency” to bring challenges identified by UK university registry managers to the attention of the European Medicines Agency. The EMA has since initiated a dialogue on these issues.

This FOI request is being filed on behalf of TranspariMED.

Yours faithfully,

Till Bruckner

Data Protection & Freedom of Information, University of Exeter

1 Atodiad

Dear Till,

 

Thank you for your request under the information Act of 2000. Your
reference number is FOI19-163

 

We will consider your request and respond in due course.

 

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

 

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Regards,

 

Jude

Information Governance Support
Tel 01392 727510

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

This email and any attachment may contain information that is
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dangos adrannau a ddyfynnir

Data Protection & Freedom of Information, University of Exeter

2 Atodiad

Dear Till,   

 

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

 

Kind regards,

Information Governance Support
Tel 01392 727510

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.

 

 

dangos adrannau a ddyfynnir