Clinical trials completed or terminated between 2006 and 2015

Roedd y cais yn llwyddiannus.

Dear University of Manchester,

This FOI request is being filed on behalf of TranspariMED.

Please note that the information requested below is not available from public sources, as data on primary completion dates and the number of participants provided in trial registries other than EudraCT is frequently incorrect and sometimes missing altogether.

INCLUSION CRITERIA

The scope of this FOI request covers all interventional clinical trials completed or terminated between 01 January 2006 and 31 December 2015 for which your institution acted as the primary or lead sponsor [terms interchangeable] at the time of the completion/termination of the trial.

The scope of this FOI request includes all clinical trials that fall into IRAS category 2 “Clinical investigations or other studies of medical devices” and IRAS category 4 “Other clinical trials or clinical investigations” according to current IRAS classifications:

EXCLUSION CRITERIA

Clinical trials of investigational medicinal products (IRAS category 1, “CTMIPs”) fall outside the scope of this request.

In addition, those clinical trials of a drug/device combination that meet the detailed criteria set out in IRAS category 3 fall outside the scope of this request. (Note: Some clinical trials of a drug/device combination do *NOT* fall into IRAS category 3 and should thus be included in your response to this request.)
https://www.myresearchproject.org.uk/hel...

Trials that never started, and/or that were withdrawn before recruiting any patients, also fall outside the scope of this request, as do all non-interventional studies.

INFORMATION REQUESTED

Please provide the following information for each trial that falls within the scope of this FOI request:

(1) The trial registry ID number(s) from WHO primary registries and/or Clinicaltrials.gov (if I trial was registered on multiple trial registries, please provide all registry ID numbers)
(2) Primary completion date (actual, this may differ from date stated in registries)
(3) Number of participants (actual, this may differ from number stated in registries)
(4) A link to where trial outcomes were first reported (hyperlink in the case of tabular summary results posted onto a trial registry, DOI in the case of articles published in peer-reviewed journals, hyperlink in all other cases)

Please provide these data in Excel format.

I understand that the pandemic may be straining your capacity to respond to FOI requests. Please feel free to disregard the legally mandated response time of 20 working days. Please do respond within 40 working days.

Thank you for your time, best wishes,

Till Bruckner
TranspariMED

MTRS FOIA, University of Manchester

1 Atodiad

Dear Till,

 

I am writing to acknowledge your request under the Freedom of Information
Act 2000 received by The University of Manchester, our reference as per
the subject line.

 

The University will respond to your request within 20 working days.

 

NB Due to the evolving situation with the Covid-19 virus and the
University’s response to it, there may be a delay in receiving your
response at this time.

 

With best regards

Lisa

 

Dr Lisa Crawley l  Information Officer  l Information Governance Office
l Directorate of Compliance and Risk l  Professional Support Services |
Room G7 Christie Building  l Compliance & Risk Management Office l  The
University of Manchester  l  Oxford Road  l  Manchester  l  M13 9PL  l 
Tel +44 (0)161 275 8400  

[1]www.manchester.ac.uk

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We are all responsible for protecting person identifying data held by the
University, including who we share that data with. Stop and think before
you send your email.  For further guidance see:
[3]www.dataprotection.manchester.ac.uk

 

References

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Dear MTRS FOIA,

Feedback from trial sponsors who received the original FOI request suggests that some institutions may struggle to provide the data because their existing datasets are not structured in line with IRAS categories, but instead only split trials into CTIMPs versus non-CTIMPs.

In order to lessen the burden to responding to this request, you may instead adopt the following inclusion and exclusion criteria if you wish to do so:

INCLUSION AND EXCLUSION CRITERIA

The scope of this FOI request covers all interventional clinical trials completed or terminated between 01 January 2006 and 31 December 2015 for which your institution acted as the primary or lead sponsor [terms interchangeable] at the time of the completion/termination of the trial.

The scope of this FOI request includes all clinical trials, defined as studies that fall into IRAS categories 1-4, with the exception of Clinical trials of investigational medicinal products (CTIMPs) as defined by the MHRA.

CTIMPs, trials that never started, and/or trials that were withdrawn before recruiting any patients, fall outside the scope of this request, as do all non-interventional studies.

Yours sincerely,

Till Bruckner

MTRS FOIA, University of Manchester

Dear Till,

Thank you for your email. Your clarification has been passed on to the responding department.

Kind regards

Sharon

Sharon Glen | Information Officer | Information Governance Office | Directorate of Compliance and Risk |Professional Services | G7 Christie Building | The University of Manchester | Oxford Road | Manchester | M13 9PL | Tel +44(0) 161 306 7549| www.manchester.ac.uk

We are all responsible for protecting personal data held by the University, including who we share that data with. Stop and think before you send your email.  For further guidance see: www.dataprotection.manchester.ac.uk

dangos adrannau a ddyfynnir

MTRS FOIA, University of Manchester

2 Atodiad

Dear Till,

 

Thank you for your request for information received by The University of
Manchester on 15 April 2020 which was as follows:

 

INFORMATION REQUESTED

 

Please provide the following information for each trial that falls within
the scope of this FOI request:

 

(1) The trial registry ID number(s) from WHO primary registries and/or
Clinicaltrials.gov (if I trial was registered on multiple trial
registries, please provide all registry ID numbers)

(2) Primary completion date (actual, this may differ from date stated in
registries)

(3) Number of participants (actual, this may differ from number stated in
registries)

(4) A link to where trial outcomes were first reported (hyperlink in the
case of tabular summary results posted onto a trial registry, DOI in the
case of articles published in peer-reviewed journals, hyperlink in all
other cases)

 

On 27 April 2020 you sent the following clarification with regard to the
scope of your request:

 

INCLUSION AND EXCLUSION CRITERIA

 

The scope of this FOI request covers all interventional clinical trials
completed or terminated between 01 January 2006 and 31 December 2015 for
which your institution acted as the primary or lead sponsor [terms
interchangeable] at the time of the completion/termination of the trial.

 

The scope of this FOI request includes all clinical trials, defined as
studies that fall into IRAS categories 1-4, with the exception of Clinical
trials of investigational medicinal products (CTIMPs) as defined by the
MHRA.

 

CTIMPs, trials that never started, and/or trials that were withdrawn
before recruiting any patients, fall outside the scope of this request, as
do all non-interventional studies.

 

The University has now considered your request and the information you are
seeking can be found in the attached spread-sheet entitled “FOI 020-210
UOM STUDIES”. Please note the following with regard to the provision of
this information:

 

·         The data has been extracted from clinicaltrials.gov, ISRCTN and
our own records.

 

·         The distinction between the different study types on IRAS has
only been recorded on our system since 30^th September 2013 when clinical
registration became a condition of NHS REC approval for all studies
falling into the first 4 categories of IRAS. Therefore, we are not able to
determine the IRAS category for some of the earlier studies (approved
prior to 30^th September 2013). The studies have been included if they are
listed on clinicaltrials.gov or ISRCTN and presumed interventional unless
stated otherwise. The data was crossed-checked with EudraCT to remove any
CTIMPs.

 

·         There have been a number of changes to the processes for
managing and overseeing these studies from a sponsor perspective,
including the number of offices involved. There may be interventional
studies that were set-up prior to 2013 that have not been included in the
list because they have not been registered on clinicaltrials.gov or ISRCTN
and cannot be detected via our normal system. The only way to capture all
of the studies is to review each of the individual applications which is
not feasible within the 18 hour ‘Appropriate Limit’ as defined in the
Freedom of Information and Data Protection (Appropriate Limit and Fees)
Regulations 2004 due to (1) the number of studies that would need to be
reviewed, (2) some study files are held as paper records and would have to
be searched manually and (3) depending on when the study ended some
records may have been archived resulting in efforts to retrieve them from
the archive. These tasks unfortunately cannot be completed within 18 hours
and as such, Section 12 of the Freedom of Information Act 2000 applies and
regrettably this task cannot be undertaken at this stage. This email
serves to act as a refusal notice for this part of your request, as per
Section 17 (5) of the Act. However we have been able to provide the
attached as it was readily extractable within the time limit and we hope
that this is of assistance to you. It does not affect our legal right to
rely on the fees regulations in relation to a full response to this
request.

 

·         Please also bear in mind that depending on when the study ended
some records may have been destroyed in line with UoM records retention
schedule/funder requirements.

 

I hope the attached is of use to you however if you feel that The
University of Manchester has refused access to information to which you
are entitled, or has not dealt with your request appropriately under the
FOIA, you have a right of appeal.

 

An appeal in the first instance should be directed to the Information
Governance Office at [1][email address]. You should include: 

·         details of your initial request

·         any other relevant information

 

You must make this appeal within 40 working days from receipt of your
response. We will not accept appeals received after this date, as per the
Freedom of Information Code of Practice, Section 5.3.

 

The University will deal with your appeal within a reasonable time, and
will inform you of the projected time scale on receipt of your complaint.
You are also welcome to contact the Information Governance Office with
informal questions about the handling of your request. 

 

After The University’s internal appeals procedure has been exhausted, you
have a further right of appeal to the Information Commissioner’s
Office. Details of this procedure can be found at [2]www.ico.org.uk.

 

Kind regards

 

Sharon

 

Sharon Glen | Information Officer | Information Governance Office |
Directorate of Compliance and Risk |Professional Services | G7 Christie
Building | The University of Manchester | Oxford Road | Manchester | M13
9PL | Tel +44(0) 161 306 7549| [3]www.manchester.ac.uk

[4]data_matters_logo2-(3)

We are all responsible for protecting personal data held by the
University, including who we share that data with. Stop and think before
you send your email.  For further guidance see:
[5]www.dataprotection.manchester.ac.uk

 

References

Visible links
1. mailto:[email address]
2. http://www.ico.org.uk/
3. http://www.manchester.ac.uk/
5. http://www.dataprotection.manchester.ac....