Clinical trial reporting: prospective and retrospective
Dear University of Reading,
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
Dear Till Bruckner,
This is to acknowledge receipt of your request for information below and to let you know it is being processed.
We'll get back to you as soon as we can, but in any case within 20 working days from 30/03/2019.
In the meantime, if you wish to add any further details or check on progress, please reply to this message, quoting reference number: IMPS#02433, so that we can track your input and respond promptly.
Yours sincerely,
Sinead Latham
Information Management & Policy Services (IMPS), University of Reading, Whiteknights, Reading, RG6 6AH
t: +44 (0)118 378 8981 www.reading.ac.uk/foia
Dear Till Bruckner,
We have completed the compilation of information in response to your
request.
We can confirm that we do not hold the information specified in your
request. Our responses are given below each limb of your request.
We are required to include details of our complaints procedures, including
your rights to apply to the Information Commissioner. The procedure is
detailed in our Freedom of Information and Environmental Information
Regulations policy on the web at
[1]www.reading.ac.uk/freedom-of-information-policy
If we are unable to resolve any complaint, you can complain to the
Information Commissioner, the independent body who oversees the access to
information regimes:
Information Commissioner
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Email: [2][email address]
Yours sincerely,
Sinead Latham
Information Compliance Officer
Information Management & Policy Services (IMPS), University of Reading,
Whiteknights, Reading, RG6 6AH
[3][University of Reading request email] t: +44 (0)118 378 8981
[4]www.reading.ac.uk/foia
Dear University of Reading,
Please pass this on to the person who conducts Freedom of Information reviews.
I am writing to request an internal review of University of Reading's handling of my FOI request 'Clinical trial reporting: prospective and retrospective'.
The University responsed to all three questions that:
"We can confirm that we do not hold the information specified in your request."
These were questions about the University's policies and processes. The University may or may not have such policies and processes, but it certainly does hold information on whether it has them or not.
Therefore, please review and provide answers to all three original FOI questions, as originally requested. Brief answers will suffice.
SOME CONTEXT THAT MAY THE USEFUL
Public data shows that the University has sponsored clinical trials (as defined by the WHO) on Clinicaltrials.gov and on ISRCTN.
https://clinicaltrials.gov/ct2/results?c...
https://www.isrctn.com/search?q=&fil...
Other universities' responses to identical FOI questions may be informative:
https://www.whatdotheyknow.com/user/till...
Also the Transparency Tools here:
https://www.transparimed.org/resources
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
Dear Till Bruckner,
This email is to formally acknowledge your request for an internal review in respect of information not being held by the University.
The internal review will be carried out as per our Freedom of Information Policy. http://www.reading.ac.uk/web/files/imps/...
We will endeavour to respond to you as soon as possible but in any case, in line with the policy referenced above.
Kind regards,
Sinead Latham
Information Compliance Officer
Information Management & Policy Services (IMPS), University of Reading, Whiteknights, Reading, RG6 6AH
t: +44 (0)118 378 8981 www.reading.ac.uk/internal/imps
Dear Till Bruckner,
Thank you for your patience while we reviewed your request.
The University does not hold information in respect of limbs 1, 2 or 3 of your request. We have provided further explanation below and re-included the explanatory text, which after reviewing our previous response we realise may not have been sufficiently explained or suitably clear previously, so please do accept our apologies for this. We did also wonder whether you had read down to the end of our reply where we provided additional comments under each question and have repeated these below just in case.
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.
No, the university has not 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. Please see explanatory text below.
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.
No, the university has not 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. Please see explanatory text below.
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.
No, the university has not developed a plan for retrospectively reporting the results of past trials that have remained unreported please see explanatory text below.
Explanatory text -
The University has no internal formal policies, systems and processes to ensure that, 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. Usual practice is that, funder and regulatory authorities require and monitor the process is completed within the defined timelines, therefore, no additional administration by the University, as Sponsor, is deemed necessary. With the administration of the trials delegated to School level, an audit of past trials has not been conducted and is not planned at an institutional level, to collate this information for the purposes of responding to an FOI request would likely engage exemption section 12 (cost refusal) as it would require a search at School and department level and there are over 55 Schools and Departments.
This concludes our internal review.
If you are still not satisfied with the way we have handled your request, or our response, you can you can complain to the Information Commissioner, the independent body who oversees the access to information regimes:
Information Commissioner
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Email: [email address]
Best regards
Rebecca Daniells
Data Protection Officer
Information Management & Policy Services (IMPS), Academic and Governance Services, University of Reading
+44 (0)118 378 8981 www.reading.ac.uk/imps
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