University clinical trial reporting systems and plans

The request was successful.

Dear Sir/Madam,

I am filing this freedom of information request on behalf of TranspariMED.

Evidence recently submitted to parliament indicates that the university failed to upload any due clinical trial results onto the European trial registry EudraCT between February and October 2019:
http://data.parliament.uk/writtenevidenc...

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 and ISRCTN) 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 that are listed on trial registries, including all interventional 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.

Q4. By when does the university plan to have uploaded all due clinical trial results onto EudraCT?

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.”

Note:

A summary of the recent parliamentary session on clinical trial transparency, and a collection of useful tools for trial sponsors, can be found on the TranspariMED website.

Thank you for your time, best wishes,

Till Bruckner

Freedom of Information, St George's University of London

Thank you for your Freedom of Information enquiry.  We will deal with your
request in due course, in line with the Freedom of Information Act.

Sheila Durkin | Governance Manager
Governance Legal and Assurance Services
St George’s, University of London
Cranmer Terrace | Tooting | London | SW17 0RE
+44 (0)20 8725 4698

[email address]

Freedom of Information, St George's University of London

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We attach our response to your Freedom of Information request.
Best wishes.

Sheila Durkin | Governance Manager
Governance Legal and Assurance Services
St George’s, University of London
Cranmer Terrace | Tooting | London | SW17 0RE
+44 (0)20 8725 4698
[email address]

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