NHS Trust clinical trial reporting systems and plans

The request was successful.

Dear Sir/Madam,

I am filing this freedom of information request on behalf of TranspariMED.

Evidence recently submitted to parliament indicates that the university failed to upload any due clinical trial results onto the European trial registry EudraCT between February and October 2019:
http://data.parliament.uk/writtenevidenc...

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 and ISRCTN) 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 that are listed on trial registries, including all interventional 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.

Q4. By when does the university plan to have uploaded all due clinical trial results onto EudraCT?

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.”

Note:

A summary of the recent parliamentary session on clinical trial transparency, and a collection of useful tools for trial sponsors, can be found on the TranspariMED website.

Thank you for your time, best wishes,

Till Bruckner

Thank you for your Freedom of Information request. Please note that in September 2015 Chelsea and Westminster Hospital NHS Foundation Trust merged with West Middlesex University Hospital so our response will include information for both trusts. There is no need to send in a separate request.
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FOI 2019 702

Dear Requester

Thank you for your information request received by us on 9/11/2019
This request has been handled under the Freedom of Information Act 2000.
Please note that Chelsea and Westminster Hospital NHS Foundation Trust merged with West Middlesex University Hospital in September 2015, for this reason our response covers both sites.

Your request and our response

Q1. Has the TRUST put into place policies, systems and processes that ensure that in future, every clinical trial sponsored by the TRUST will post its summary results on every WHO primary trial registry (including Clinicaltrials.gov and ISRCTN) 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 Trust does not currently have a formal policy in place to ensure this but we have a functioning working practice to do this which is delegated to the Chief Investigator and his/her team. This is currently under review and we expect any new processes to be in place by the end of March 2020.


Q2. Has the TRUST conducted a registry-data based audit of all clinical trials it has sponsored in the past that are listed on trial registries, including all interventional 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.

We are aware of all studies on EudraCT and Clinicaltrials.gov that are registered against the Trust. The R&D team is currently following up on the outstanding reports, which were historically delegated to CIs. We expect to have completed this by the end of March 2020.



Q3. Has the TRUST 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.

The Trust's R&D Unit is aware of all unreported studies and has contacted the relevant Chief Investigators requesting completion of these reports. We expect this exercise to be completed by the end of March 2020.


Q4. By when does the TRUST plan to have uploaded all due clinical trial results onto EudraCT?

March 2020.

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Chelsea and Westminster Hospital NHS Foundation Trust
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Yours sincerely
The Information Governance team
Chelsea and Westminster Hospital NHS Foundation Trust
Email: [email address]

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