Clinical trial sponsorship in the UK in 2014 and 2019

The request was successful.

Dear Health Research Authority,

This FOI request is being filed on behalf of TranspariMED.

Please provide the following information:

Item 1.

An Excel spreadsheet of all clinical trial sponsors that received ethics approval in the UK for at least one interventional clinical trial during the calendar year 2014, with one line per sponsor, containing the following four data fields for each sponsor:
1 Sponsor name
2 Number of CTIMPs that received ethics approval
3 Number of non-CTIMP interventional clinical trials that received ethics approval
4 Total number of interventional clinical trials that received ethics approval

Item 2.

An Excel spreadsheet of all clinical trial sponsors that received ethics approval in the UK for at least one interventional clinical trial during the calendar year 2019, with one line per sponsor, containing the following four data fields for each sponsor:
1 Sponsor name
2 Number of CTIMPs that received ethics approval
3 Number of non-CTIMP interventional clinical trials that received ethics approval
4 Total number of interventional clinical trials that received ethics approval

Item 3.

The total number of interventional clinical trials that were refused ethics approval during the calendar year 2019, and a breakdown of this figure into CTIMPs and non-CTIMPs. (Aggregate data only.)

Item 4.

The definition of “interventional clinical trial” used by the HRA to determine which studies to include in its responses to the above questions.

Note: The scope of this FOI is deliberately restricted to the years 2014 and 2019 to limit the workload required by the HRA to compile a response. However, data for additional years (ideally including additional information, such as trial distribution by region, sponsor type, etc) would be of great interest for UK science policy makers, other NHS bodies, research funders, industry, and meta-researchers. HRA might wish to consider proactively publishing such data on its website in future.

Yours faithfully,

Till Bruckner

FOI, HRA (HEALTH RESEARCH AUTHORITY), Health Research Authority

Dear Till,

 

Freedom of Information (FOI) Act request

 

Thank you for your email dated 29 January 2020 requesting the following
information:

 

o Item 1.

An Excel spreadsheet of all clinical trial sponsors that received ethics
approval in the UK for at least one interventional clinical trial during
the calendar year 2014, with one line per sponsor, containing the
following four data fields for each sponsor:

1 Sponsor name

2 Number of CTIMPs that received ethics approval

3 Number of non-CTIMP interventional clinical trials that received ethics
approval

4 Total number of interventional clinical trials that received ethics
approval

 

o Item 2.

An Excel spreadsheet of all clinical trial sponsors that received ethics
approval in the UK for at least one interventional clinical trial during
the calendar year 2019, with one line per sponsor, containing the
following four data fields for each sponsor:

1 Sponsor name

2 Number of CTIMPs that received ethics approval

3 Number of non-CTIMP interventional clinical trials that received ethics
approval

4 Total number of interventional clinical trials that received ethics
approval

 

o Item 3.

The total number of interventional clinical trials that were refused
ethics approval during the calendar year 2019, and a breakdown of this
figure into CTIMPs and non-CTIMPs. (Aggregate data only.)

 

o Item 4.

The definition of “interventional clinical trial” that we used to
determine which studies to include in the responses to the above
questions.

 

You have asked that we note that the scope of this FOI is deliberately
restricted to the years 2014 and 2019 to limit the workload required for
us to compile a response. However, data for additional years (ideally
including additional information, such as trial distribution by region,
sponsor type, etc) would be of great interest for UK science policy
makers, other NHS bodies, research funders, industry, and meta-researchers
and that we might wish to consider proactively publishing such data on our
website in future.

 

Your request is being handled under the Freedom of Information (FOI) Act
and has been referred to the appropriate personnel for investigation.  We
will provide you with a response as soon as possible, but no later than 26
February 2020.

 

Kind regards,

Susannah

       

Freedom of Information

Health Research Authority

HRA | Skipton House, 80 London Road | London | SE1 6LH

T. 0207 972 2487

E. [1][HRA request email]

W. [2]www.hra.nhs.uk

 

Our latest guidance on how the upcoming GDPR affects health research is
[3]now live

 

Sign up to receive our newsletter [4]HRA Latest.

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1 Attachment

Dear Till,

 

Freedom of Information (FOI) Act request

 

We are writing in response to your request for information, under the FOI
Act, dated 29 January 2020.  Thank you for your enquiry. You requested the
following information:

 

o Item 1.

An Excel spreadsheet of all clinical trial sponsors that received ethics
approval in the UK for at least one interventional clinical trial during
the calendar year 2014, with one line per sponsor, containing the
following four data fields for each sponsor:

1 Sponsor name

2 Number of CTIMPs that received ethics approval

3 Number of non-CTIMP interventional clinical trials that received ethics
approval

4 Total number of interventional clinical trials that received ethics
approval

 

o Item 2.

An Excel spreadsheet of all clinical trial sponsors that received ethics
approval in the UK for at least one interventional clinical trial during
the calendar year 2019, with one line per sponsor, containing the
following four data fields for each sponsor:

1 Sponsor name

2 Number of CTIMPs that received ethics approval

3 Number of non-CTIMP interventional clinical trials that received ethics
approval

4 Total number of interventional clinical trials that received ethics
approval

 

o Item 3.

The total number of interventional clinical trials that were refused
ethics approval during the calendar year 2019, and a breakdown of this
figure into CTIMPs and non-CTIMPs. (Aggregate data only.)

 

o Item 4.

The definition of “interventional clinical trial” that we used to
determine which studies to include in the responses to the above
questions.

 

You have asked that we note that the scope of this FOI is deliberately
restricted to the years 2014 and 2019 to limit the workload required for
us to compile a response. However, data for additional years (ideally
including additional information, such as trial distribution by region,
sponsor type, etc) would be of great interest for UK science policy
makers, other NHS bodies, research funders, industry, and meta-researchers
and that we might wish to consider proactively publishing such data on our
website in future.

 

Our response is as follows:

 

o Items 1 and 2

Please find attached a spreadsheet which details a list of all
applications with REC Favourable Opinion for the top 4 categories of IRAS
(Clinical trial of an investigational medicinal product, Clinical
investigation or other study of a medical device, Combined trial of an
investigational medicinal product and an investigational medical device,
Other trial to study a novel intervention or randomised clinical trial to
compare interventions in clinical practice)  for 2014 and 2019.

 1. There is a separate tab for each year, and column H of each page
provides the sponsor name which you can filter by to obtain the
information that you have requested
 2. The number of CTIMPs that received ethics approval can be
calculated by filtering the entries in column D to ‘Clinical trial
of an investigational medicinal product’
 3. The number of non-CTIMP interventional clinical trials that
received ethics approval can be calculated by filtering the entries
in column D to not include ‘Clinical trial of an investigational
medicinal product’ and ‘Combined trial of an investigational
medicinal product and an investigational medical device’
 4. The total number of interventional clinical trials that received
ethics approval can be calculated through a total count of the rows
on each of the pages

 

o Item 3

The total number of interventional clinical trials that received an
unfavourable opinion during the calendar year 2019, broken down into
CTIMPS and non-CTIMPs (aggregate data only) is as follows:

 

  CTIMPs Non-CTIMPs
Unfavourable Opinion issued in 2019 21 37

 

 

 

 

o Item 4

The definition of ‘interventional clinical trial’ that we used when
determining which studies to include in response to the information
requested was, as set out above, the data contained in HARP and IRAS for
the top 4 categories of IRAS

 

We note the additional information that you have provided in terms of the
restrictions that you placed on the scope of the information requested,
and your request for any additional information that we can provide. With
this in mind, we have included as much additional information as we were
able to extract in the spreadsheet that is attached.

 

We hope that this information is helpful to you, but should you require
further clarification, please let us know.

 

If you are unhappy about the way in which your request has been handled,
the HRA has an internal complaints procedure through which you can raise
any concerns.  Further details of this procedure may be obtained by
contacting the Complaints Manager via [1][HRA request email].  If you are
dissatisfied with the outcome of the complaints procedure, you can apply
to the Information Commissioner’s Office (ICO), who will consider whether
we, as a public authority, have complied with its obligations under the
Act, and can require the HRA to remedy any problems.  You can find out
more about how to do this, and about the Act in general, on their website
[2]www.ico.org.uk.  Complaints should be sent to:

FOI Complaints Resolution – Information Commissioner’s Office

Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF

 

Kind regards,

Susannah

 

       

Freedom of Information

Health Research Authority

HRA | Skipton House, 80 London Road | London | SE1 6LH

T. 0207 972 2487

E. [3][email address]

W. [4]www.hra.nhs.uk

 

Our latest guidance on how the upcoming GDPR affects health research is
[5]now live

 

Sign up to receive our newsletter [6]HRA Latest.
 

Important: Our email is changing to [7][email address] in February
2020. Please update your records accordingly. After our email has
changed, you will receive an out of office response from our old address
with a reminder of our new details.

 

From: FOI, HRA (HEALTH RESEARCH AUTHORITY)
Sent: 31 January 2020 13:50
To: [8][FOI #639802 email]
Subject: FOI acknowledgement - 1920/FOI/064

 

Dear Till,

 

Freedom of Information (FOI) Act request

 

Thank you for your email dated 29 January 2020 requesting the following
information:

 

o Item 1.

An Excel spreadsheet of all clinical trial sponsors that received ethics
approval in the UK for at least one interventional clinical trial during
the calendar year 2014, with one line per sponsor, containing the
following four data fields for each sponsor:

1 Sponsor name

2 Number of CTIMPs that received ethics approval

3 Number of non-CTIMP interventional clinical trials that received ethics
approval

4 Total number of interventional clinical trials that received ethics
approval

 

o Item 2.

An Excel spreadsheet of all clinical trial sponsors that received ethics
approval in the UK for at least one interventional clinical trial during
the calendar year 2019, with one line per sponsor, containing the
following four data fields for each sponsor:

1 Sponsor name

2 Number of CTIMPs that received ethics approval

3 Number of non-CTIMP interventional clinical trials that received ethics
approval

4 Total number of interventional clinical trials that received ethics
approval

 

o Item 3.

The total number of interventional clinical trials that were refused
ethics approval during the calendar year 2019, and a breakdown of this
figure into CTIMPs and non-CTIMPs. (Aggregate data only.)

 

o Item 4.

The definition of “interventional clinical trial” that we used to
determine which studies to include in the responses to the above
questions.

 

You have asked that we note that the scope of this FOI is deliberately
restricted to the years 2014 and 2019 to limit the workload required for
us to compile a response. However, data for additional years (ideally
including additional information, such as trial distribution by region,
sponsor type, etc) would be of great interest for UK science policy
makers, other NHS bodies, research funders, industry, and meta-researchers
and that we might wish to consider proactively publishing such data on our
website in future.

 

Your request is being handled under the Freedom of Information (FOI) Act
and has been referred to the appropriate personnel for investigation.  We
will provide you with a response as soon as possible, but no later than 26
February 2020.

 

Kind regards,

Susannah

       

Freedom of Information

Health Research Authority

HRA | Skipton House, 80 London Road | London | SE1 6LH

T. 0207 972 2487

E. [9][HRA request email]

W. [10]www.hra.nhs.uk

 

Our latest guidance on how the upcoming GDPR affects health research is
[11]now live

 

Sign up to receive our newsletter [12]HRA Latest.

show quoted sections