Clinical trial reporting: prospective and retrospective

Till Bruckner made this Rhyddid Gwybodaeth request to University of Leeds

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 University of Leeds,

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, University of Leeds

Dear Till

I can confirm receipt of the request below, dated 30 March 2019. 

Your request is being dealt with under the terms of the Freedom of Information Act 2000 and will be answered within twenty working days.  As such, you should expect to hear from the University in response by 1 May 2019, if, in the meantime, you have any queries about the request, please don’t hesitate to contact me.   

Kind regards

Tracey Crombie
PA to the Legal Adviser
University of Leeds
LS2 9JT
Tel:  0113 343 4078 (NB 8am-4pm)
Fax:  0113 343 3925

This communication is intended solely for the addressee, is strictly confidential and may also be legally privileged.  If you are not the addressee please do not read, print, re-transmit, store or act in reliance on it or any attachments.  Instead, please contact Tracey Crombie on the above telephone number.

Any liability (in negligence or otherwise) arising from any third party acting, or refraining from acting, on any information contained in this email is excluded.

It is the responsibility of the receiver of this email to ensure that any onward transmission or use of this email (including attachments) will not adversely affect their systems or data contained on their systems.  Receivers are advised to carry out virus checks.  The University of Leeds accepts no responsibility with regard to the communication or other use of this email.

dangos adrannau a ddyfynnir

Freedom of Information, University of Leeds

Dear Mr Bruckner,

 

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.

 

As part of its overarching quality management system (QMS), the University
has a standard operating procedure (SOP) in place, which details the
systems and processes for ensuring that the outcome of CTIMP clinical
trials, sponsored by the University, are posted on relevant WHO
registries. The procedure was refreshed as part of our response to an MHRA
inspection in 2015.

 

Our Clinical Trials Research Unit (CTRU) is also developing a Transparency
Policy which details requirements to publish primary and secondary
endpoint results within 12 months of the end of trial. Publishing is
defined as results being uploaded onto the relevant trial registry, in
addition to the National Institute for Health Research Journal and/ or
scholarly journal. CTIMP reporting requirements are additionally in line
with current EMA regulatory requirements i.e. uploading onto the EudraCT
database.

  

A new SOP for non-CTIMP clinical trials, which will mirror the CTIMP
clinical trials SOP, is being developed and we expect it to be in
operation by the start of the next academic year. 

 

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.

 

Our CTIMP clinical trials SOP defines how we maintain oversight of the
reporting of trial results and we hold a 'master trial list' of all
sponsored studies with an associated workbook which sets out a full audit
trail of the status of trials which are within their reporting period.

 

We are in the midst of auditing our non-CTIMP clinical trials, which has
involved a review of all studies published in clinical trials.gov. An
action plan is being developed to address any reporting discrepancies,
which will be addressed by the beginning of the next academic year (as
above).

 

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.

 

Our CTRU has been compliant with retrospective reporting requirements for
CTIMP trials onto the EudraCT database since the EMA news release in
2014.  The CTRU’s longstanding position has been to publish trial results
into a peer reviewed academic journal or conference. The University has
been more broadly compliant since the revised QMS was put in place in
2016. For non-CTIMP clinical trials, an action plan is being developed (as
described above).

 

 

I hope this is helpful in resolving your query. If you have any questions
about this email, however, please don't hesitate to contact me.

 

If you are unhappy with the service you have received in relation to your
request and wish to make a complaint or request a review of our decision,
you should write to or email directly Mr D Wardle, Deputy Secretary, The
University of Leeds, Leeds, LS2 9JT ([1][email address]). You
should do so within 40 working days of receiving the University’s response
to your request. Further information about how the University manages
Freedom of Information requests and about our complaints procedure is also
available on our website ([2]www.leeds.ac.uk).

 

If you are not content with the outcome of the internal review, you have
the right to apply directly to the Information Commissioner for a
decision.  Generally, the ICO cannot make a decision unless you have
exhausted the review/complaints procedure provided by the University.  The
Information Commissioner can be contacted at:  Information Commissioner’s
Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF.

 

 

 

 

 

dangos adrannau a ddyfynnir

Dear University of Leeds,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of University of Leeds's handling of my FOI request 'Clinical trial reporting: prospective and retrospective'.

Thank you for the timely and informative response, which is entirely satisfactory overall.

However, there is one piece of information I requested that the University omitted to supply. In response to Q2, the University only provided information related to Clinicaltrials.gov, but not to ISRCTN.

Please clarify whether or not the University plans also extend to the efforts described in its answer to Q2 to ISRCTN.

A very brief answer will suffice. Thank you for your time.

FYI:
https://www.isrctn.com/search?q=&fil...

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/c...

Yours faithfully,

Till Bruckner

Tracey Crombie,

Dear Mr Bruckner

Further to your email below, our oversight of ISRCTN material is in line with the answers we provided for Eudract. It is used mainly by our CTRU, where reporting is integral to routine processes.

I hope this is helpful in resolving your query.

If you are unhappy with the service you have received in relation to your request and wish to make a complaint or request a review of our decision, you should write to or email directly Mr D Wardle, Deputy Secretary, The University of Leeds, Leeds, LS2 9JT ([email address]). You should do so within 40 working days of receiving the University’s response to your request. Further information about how the University manages Freedom of Information requests and about our complaints procedure is also available on our website (www.leeds.ac.uk).

If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision.  Generally, the ICO cannot make a decision unless you have exhausted the review/complaints procedure provided by the University.  The Information Commissioner can be contacted at:  Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF.

Best wishes,

Tracey Crombie
PA to the Legal Adviser
University of Leeds
LS2 9JT
Tel:  0113 343 4078 (NB 8am-4pm)
Fax:  0113 343 3925

This communication is intended solely for the addressee, is strictly confidential and may also be legally privileged.  If you are not the addressee please do not read, print, re-transmit, store or act in reliance on it or any attachments.  Instead, please contact Tracey Crombie on the above telephone number.

Any liability (in negligence or otherwise) arising from any third party acting, or refraining from acting, on any information contained in this email is excluded.

It is the responsibility of the receiver of this email to ensure that any onward transmission or use of this email (including attachments) will not adversely affect their systems or data contained on their systems.  Receivers are advised to carry out virus checks.  The University of Leeds accepts no responsibility with regard to the communication or other use of this email.

dangos adrannau a ddyfynnir