Clinical trial reporting: prospective and retrospective

The request was successful.

Dear Liverpool School of 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

Freedom of Information, Liverpool School of Tropical Medicine

1 Attachment

Dear Till,

Please find attached acknowledgement of receipt of your request.

Emily

show quoted sections

Emily Griffiths, Liverpool School of Tropical Medicine

1 Attachment

Dear Till,

Please find attached our response to your request.

Emily

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From: Till Bruckner <[FOI #565241 email]>
Sent: 30 March 2019 18:57
To: Freedom of Information
Subject: Freedom of Information request - Clinical trial reporting:
prospective and retrospective
 
Dear Liverpool School of 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

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