Clinical trials annually receiving ethics approval in the UK

Till Bruckner made this Freedom of Information request to Health Research Authority

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Dear Health Research Authority,

1. What is the number of clinical trials that received ethics approval in the UK during the calendar year 2017?

2. Please provide a breakdown of the number of trials receiving ethics approval in 2017 by trial phase

3. Please provide a breakdown of the number of trials receiving ethics approval in 2017 by trial sponsor category (ideally: commercial vs university vs NHS Trust vs other)

For the purpose of this request, a clinical trial is defined as set out by 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."
https://www.who.int/topics/clinical_tria...

Yours faithfully,

Till Bruckner

FOI, HRA (HEALTH RESEARCH AUTHORITY),

Dear Till,

 

Freedom of Information (FOI) Act request

 

Thank you for your email dated 12 November 2018 requesting the following
information:

 

1.    The number of clinical trials that received ethics approval in the
UK during the calendar year 2017

2.    A breakdown of the number of trials receiving ethics approval in
2017 by trial phase

3.    A breakdown of the number of trials receiving ethics approval in
2017 by trial sponsor category (ideally: commercial vs university vs NHS
Trust vs other)

 

You have stated that for the purpose of your request, a clinical trial is
defined as set out by the WHO definition:

 

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 11
December 2018.

 

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.
 

 

show quoted sections

FOI, HRA (HEALTH RESEARCH AUTHORITY),

Dear Till,

 

Freedom of Information (FOI) Act request

 

We are writing in response to your request for information, under the FOI
Act, dated 12 November 2018.  Thank you for your enquiry. You requested
the following information:

 

1.       The number of clinical trials that received ethics approval in
the UK during the calendar year 2017

2.       A breakdown of the number of trials receiving ethics approval in
2017 by trial phase

3.       A breakdown of the number of trials receiving ethics approval in
2017 by trial sponsor category (ideally: commercial vs university vs NHS
Trust vs other)

 

Our response is as follows:

 

1.       The number of clinical trials that received ethics approval in
the UK during the calendar year 2017 is 1858.

 

2.       We are only able to provide this break down for clinical trials
of medicinal products. The total clinical trials of medicinal products is
892, which is broken down as follows:

 

Phase I 259
Phase I/II 43
Phase I/III 1
Phase II 257
Phase I/II/III 1
Phase II/III 6
Phase III  279
Phase III/IV 2
Phase IV 43
No response 1

 

3.       The number of trials receiving ethics approval in 2017 broken
down by trial sponsor category is:

 

Of 1858 trials

 

Academic 494
Commercial 855
NHS/HSC 391
Other 118

 

 

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][HRA request email]

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.
 

 

 

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Dear FOI, HRA (HEALTH RESEARCH AUTHORITY),

thank you very much for the timely and comprehensive response.

Yours sincerely,

Till Bruckner