Clinical trial reporting: prospective and retrospective

Till Bruckner made this Rhyddid Gwybodaeth request to Cardiff University

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

Roedd y cais yn llwyddiannus.

Dear Cardiff University,

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

InfoRequest, Cardiff University

Dear Till

I acknowledge receipt of your email received by this office on 30 March 2019 in which you requested information regarding clinical trial reporting.

Your request will now be dealt with under the Freedom of Information Act 2000 and has been allocated reference FOI19-145 which should be quoted in all correspondence. We will respond to your request within 20 working days starting the next working day after receipt, therefore you can expect to receive a response no later than 30 April 2019.

Where we consider that we will not be able to meet this deadline or if further time is required to consider the public interest test we will contact you as soon as possible and give you a revised date for response.

In some circumstances a fee may be payable and, if that is the case, we will let you know. A fees notice will be issued to you, and you will be required to pay before we will proceed to deal with your request.

Yours sincerely

Gail Thomas
Swyddog Sicrwydd
Adran Cynllunio Strategol a Llywodraethu
Prifysgol Caerdydd
2il Lawr, Friary House
Heol y Brodyr Llwydion
Caerdydd
CF10 3AE
Ffôn: +44 (029) 2087 5327
Ebost : [email address]  

Mae'r Brifysgol yn croesawu gohebiaeth yn Gymraeg neu'n Saesneg. Ni fydd gohebu yn Gymraeg yn creu unrhwy oedi.
Gail Thomas
Assurance Officer
Strategic Planning and Governance
Cardiff University
2nd Floor, Friary House
Greyfriars Road
Cardiff
CF10 3AE
Tel: +44 (029) 2087 5327
Email: [email address] 

The University welcomes correspondence in Welsh or English. Corresponding in Welsh will not lead to any delay.

dangos adrannau a ddyfynnir

InfoRequest, Cardiff University

Dear Till

 

I am writing in response to your Freedom of Information request dated 30
March 2019 in which you requested information regarding clinical trial
reporting.

 

For ease of reference, I have reproduced your questions below and set out
our corresponding responses.

 

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.

 

The latest draft of the University’s Code of Practice for Research
Integrity and Ethics (CoP) requires that summary results must be posted on
every relevant registry within 12 months of the trial completion.  The
updated CoP will be submitted to the University Research Integrity and
Ethics Committee for approval 21 May 2019 and is scheduled for release in
August 2019.

 

Processes in place to ensure that summary results are posted on the
relevant registries within 12 months include:

•           A Memorandum of Understanding (dated March 2018) with the
University’s Centre for Trials Research (CTR), requiring CTR to: ensure
that all trial results are placed in the public domain.

•           A Memorandum of Understanding is signed between the Sponsor,
Trials Unit and Chief Investigator for each trial. The template MoU (dated
September 2017) required the Trials Unit to ensure results are published
on or linked from the relevant public registry(ries).  A new version of
the template MoU (dated April 2019) specifies that results must be
published on the relevant registries within 12 months of trial completion.

•           Guidance for uploading trial results to EudraCT (June 2018)

•           Generation, review and approval of a Clinical Trial Report
(September 2016)

•           Study Closure SOP and Study Closure Checklist (August 2016)

 

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.

 

Yes.  Audit completed April 2018 and reported to the University’s Clinical
Trial Governance Group. 

 

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.

 

A tracker is in place and is regularly reviewed and updated at monthly
meetings between Sponsor representatives and the Centre for Trials
Research.  Progress is reported to University’s Clinical Trial Governance
Group, the Open Research Task and Finish Group and the University’s
Research Integrity and Ethics Committee.

 

Past trials that have remained unreported have been identified.  These
will require further work prior to reporting results.  A specific plan was
developed in June 2018 to utilise MSc students to address one such trial. 
This exercise has been successful.  The University is investigating using
this model for further old trials. 

 

A formal plan should be in place by June 2019.

 

I trust this information satisfies your enquiry.  The University has a
Freedom of Information Complaints Procedure should you feel dissatisfied
with this response or the way in which your request was handled.
Complaints must be made in writing and must set out why you believe the
University has not met its obligations under the Freedom of Information
Act.  You may email your complaint to [email address] where it
will be forwarded to the Director of Strategic Planning and Governance who
will be responsible for overseeing the review.

 

If you remain dissatisfied following the outcome of your complaint, you
have the right to apply directly to the Information Commissioner for
consideration.  The Information Commissioner can be contacted at the
following address: Information Commissioner's Office, Wycliffe House,
Water Lane, Wilmslow, Cheshire, SK9 5AF.

 

I would like to take this opportunity to thank you for your interest in
Cardiff University. If you require further assistance please feel free to
contact me.

 

Yours sincerely

 

 

Gail Thomas

Swyddog Sicrwydd

Adran Cynllunio Strategol a Llywodraethu

Prifysgol Caerdydd

2il Lawr, Friary House

Heol y Brodyr Llwydion

Caerdydd

CF10 3AE

Ffôn: +44 (029) 2087 5327

Ebost : [email address]  

 

Mae'r Brifysgol yn croesawu gohebiaeth yn Gymraeg neu'n Saesneg.  Ni fydd
gohebu yn Gymraeg yn creu unrhwy oedi.

Gail Thomas

Assurance Officer

Strategic Planning and Governance

Cardiff University

2nd Floor, Friary House

Greyfriars Road

Cardiff

CF10 3AE

Tel: +44 (029) 2087 5327

Email: [email address] 

 

The University welcomes correspondence in Welsh or English.  Corresponding
in Welsh will not lead to any delay.

 

 

 

 

dangos adrannau a ddyfynnir