Clinical trial reporting: prospective and retrospective

Till Bruckner made this Freedom of Information request to London School of Hygiene and Tropical Medicine

This request has been closed to new correspondence. Contact us if you think it should be reopened.

The request was successful.

Dear London School of Hygiene and Tropical Medicine,

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

LSHTM Servicedesk, London School of Hygiene and Tropical Medicine

LSHTM ServiceDesk
London School of Hygiene & Tropical Medicine

Re: Freedom of Information request - Clinical trial reporting: prospective
and retro

Thank you for your request for information under the Freedom of
Information Act.  We will process your request as soon as possible and
will respond within 20 working days.

Information on how we process Freedom of Information requests is available
on the LSHTM website at :
[1]https://www.lshtm.ac.uk/aboutus/organisa...

We may need to contact you again if we require further information from
you in order to process your request.
 
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Please do not hesitate to contact us by reply to this email if you have
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Regards,
Freedom of Information team

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LSHTM Servicedesk, London School of Hygiene and Tropical Medicine

LSHTM ServiceDesk
London School of Hygiene & Tropical Medicine

Dear Till Bruckner,

Thank you for your request for information under the Freedom of
Information Act, which I now write to provide the following response to
your questions:

Q1. 
Yes. These have been included in the standard operating procedure
“Notification of End of Study” (ref LSHTM-SOP-006-01) since June 2015,
with further details added and clarified in September 2016.  It is due for
review this year

Q2. 
Yes, for EudraCT.  We unfortunately do not have the staff to conduct a
review on all registries although this is planned when the office is fully
staffed, hopefully by end of September 2019.

Q3. 
This is an ongoing process, but no defined plan was been developed for
this.  There has been considerable difficulty in adding results to EudraCT
and for the correct trial status to appear from the Competent Authority
which has caused significant delays to adding the results.  We aim to have
all results on EudraCT by summer 2019, and to extend this to the
registries in due course.

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References

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Dear FOI team - please share the message below with the person(s) who compiled the FOI response.

Thank you for your rapid response.

FYI, we are aware of the difficulties with uploading results onto EUCTR and are in discussions with the EMA on how to remove them:
http://haiweb.org/wp-content/uploads/201...

Any issues you would like us to flag with the EMA, please share by email, address here:
https://www.transparimed.org/about

Yours faithfully,

Till Bruckner / TranspariMED

LSHTM Servicedesk, London School of Hygiene and Tropical Medicine

LSHTM ServiceDesk
London School of Hygiene & Tropical Medicine

Re: Re: Freedom of Information request - Clinical trial reporting:
prospective and r

Thank you for your request for information under the Freedom of
Information Act.  We will process your request as soon as possible and
will respond within 20 working days.

Information on how we process Freedom of Information requests is available
on the LSHTM website at :
[1]https://www.lshtm.ac.uk/aboutus/organisa...

We may need to contact you again if we require further information from
you in order to process your request.
 
We will also contact you as soon as possible if we determine that a fee
will be payable for reprographics costs (such as photocopying or printing)
or postage costs associated with your request.

Please do not hesitate to contact us by reply to this email if you have
any questions relating to your request.

Regards,
Freedom of Information team

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London School of Hygiene & Tropical Medicine
Keppel Street, London WC1E 7HT UK |  [2]www.lshtm.ac.uk

 

References

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2. http://www.lshtm.ac.uk/