Clinical trial reporting: prospective and retrospective

The request was successful.

Dear University of Aberdeen,

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

Foi, University of Aberdeen

Dear Till

I refer to your email of 30 March 2019 and, on behalf of the University, I acknowledge receipt and confirm that your request is being dealt with in terms of the Freedom of Information (Scotland) Act 2002. In terms of the Act, a reply will be sent to you within 20 working days.

Yours sincerely,

Jody McKenzie
Information Governance Officer
Information Governance Team
University of Aberdeen
Tel: 01224 27(3175)

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Foi, University of Aberdeen

Dear Till,

FREEDOM OF INFORMATION REQUEST FOI 2019-122

I refer to your email of 30 March 2019 requesting information relating to research at the University of Aberdeen.

Your request has now been considered under the Freedom of Information (Scotland) Act 2002, ‘the Act’.

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.

Researchers must confirm on which publicly available websites they have/shall register their trial before first recruit. This is emphasised in the internal procedure regarding protocol guidance for high risk trials and CTIMPs (SOP-QA-3 - available on our website. Confirmation of the registry to be used is also included in the sponsor risk assessment. Once sponsorship has been agreed the standard sponsorship letter issued to researchers emphasises that the trial must be registered on a publicly available website before first recruit and results posted no later than twelve months after completion. Registration is also checked at Site Initiation and forms part of the standard Site Initiation checklist used by internal monitors.

At close-out a similar checklist is completed by internal monitors which requests if the public register(s) have been updated, and requires confirmation of who shall upload results and when this shall be completed. These processes have been in place since 2018.

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. After the initial rapid external audit conducted by TranspariMED in 2017, the University committed to undertaking an annual audit of all CTIMPs registered on EudraCT, clinicaltrials.gov and ISRCTN to identify any that have not published results within twelve months of completion. The first audit was conducted in June 2017 (and was supplied to TranspariMED) the second was conducted in June 2018. In both audits studies which did not comply were followed up through a Results Registry Committee.

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 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.

Yes, the above Results Registry Committee identified specific staff to support researchers in addressing unreported studies. This shall be ongoing when any unreported studies are identified.

Should you be dissatisfied with this response, you have the right under the Act to request a review. A request for review must be made within 40 working days of the date of this reply. It must include your name and address for correspondence and specify the request for information and the grounds for dissatisfaction with the decision. Please send your request for review to our mailbox, [University of Aberdeen request email].

If you are unhappy with the outcome of the University’s internal review, you have the right to appeal to the Scottish Information Commissioner within six months of the date of receipt of the University’s review response. Details on how to make an appeal to the Commissioner are available at www.itspublicknowledge.info/Appeal. Should you remain dissatisfied with the Commissioner’s decision, you have a right of appeal to the Court of Session on a point of law.

Yours sincerely,

Jody McKenzie
Information Governance Officer
Information Governance Team
University of Aberdeen
Tel: 01224 27(3175)

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