Basic information on Clinical Trials approved in period of 2010-2016

Stevan Cirkovic made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was successful.

Stevan Cirkovic

Dear Medicines and Healthcare products Regulatory Agency,

Please provide me with a complete list of approved clinical trials applications in the period of 1st January 2010 to 31st March 2016.

I would require the following basic data points on each of those trials:
- Unique Trial Number
- EudraCT number
- Date applied
- Date approved
- Applicant(s)
- Sponsor(s)
- Subject of the trial
- which phase the trial was in (Phases I, II, III, post-launch trials, etc.)
- enrollment number
- Beginning of Trial date
- End of Trial date
- Latest status (e.g. completed, results available, terminated)

I would highly appreciate if this was provided in an Excel format.

Yours faithfully,

Stevan Cirkovic

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer. We endeavour to
respond to requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 16/208
       
Dear Mr Cirkovic,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 1st April 2016.
       
I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.
       
Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Stevan Cirkovic,

Thank you for your email of 1 April 2016 where you requested information about approved clinical trials applications in the period of 1st January 2010 to 31st March 2016.

I can confirm that the MHRA holds some of this information (we do not hold information on trial start date or actual numbers enrolled) . The information is exempt under Section 21 of the Freedom of Information Act (FOIA), because the information is accessible to you, as it is already in the public domain in the EU Clinical Trials Register: https://www.clinicaltrialsregister.eu/.

Note that information on Phase 1 data is not publically accessible as this this information is exempted under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOIA.

Section 41 is an absolute exemption and no consideration of the balance of public interest is required. We have considered the balance of the public interest when applying Section 43, as this is a qualified exemption. The exemption is to safeguard the commercially sensitive information / industrial secrets of a third party / commercial enterprise (which can include a Government Department). This exemption is conditional on the public interest in releasing it not outweighing the company's/commercial enterprise's right to confidentiality and the probable damage that the company/commercial enterprise could suffer as a result of the information being released. In this case we have not identified any issues which would benefit the public as a whole by being brought to their attention (examples of issues would be a major public health risk or a major procedural failure or irregularity).

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of receipt of the response to your original email, and can be made by response to this email address. Please remember to quote the reference number above in any future communications.

If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at: Information Commissioner's Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF

Yours Sincerely,

Customer Services
Communications division
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000

Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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Stevan Cirkovic

Dear MHRA Customer Services,

thank you for your response. I understand that you do not hold information on trial start dates and actual numbers enrolled.

I would like you to conduct an internal review into the following objections and ask you to consider your original decision:

1. Criteria of Section 21 of the Freedom of Information Act not met: The law stipulates that "Information which is reasonably accessible to the applicant otherwise than under section 1 is exempt information." I would argue that the information requested is in fact NOT reasonably accessible to me. This is because the download options from this page would result in unreasonable effort for me to access it and, in fact, these options hide the information requested like a needle in a haystack.

Let me explain. If you were to go to the EU Clinical Trials Register and perform a search for trials conducted in the UK in the specific time-frame requested, then the search returns 4,211 on 211 pages.[1] This is further aggravated as the information I requested is not entirely available in the summary view of the search (for example information on the phase). Hence, it becomes necessary to download the full trial data. This again is only possible by downloading a full data text file for every single one of the 211 pages. Lastly, such a text file contains a vast amount of information irrelevant to my request without filtering options, while the text file format constitutes yet another obstacle in itself.

According to the Information Commissioners Office, its Tribunal has previously ruled in a case from 2008 that if "a large amount of searching is required in order to locate the information" then it is in fact not readily accessible.[2] I find myself in that very same situation.

2. Only part of the requested information is in the public domain. The EU Clinical Trials Register clearly states that it is being gradually updated.[3] Without going into further detail, the information made available through this register is incomplete. Also, I asked for approved clinical trials - the register only covers completed trials, to my understanding. This means that you would still have to release information on any further trials not covered by the site. The ICO says: "If only part of the requested information is in the public domain, section 21 can only apply to that part of the request (subject to the circumstances of the individual applicant)." [4] Please clearly demonstrate in your review the number of trials approved in the UK in the period specified in my request.

On these grounds, I would like you to reconsider and provide me with the information requested (except for information not held as defined in your response from 3 May 2016) in a non-redundant and machine-readable form.

Yours sincerely,

Stevan Cirkovic

[1] https://www.clinicaltrialsregister.eu/ct...
[2] https://ico.org.uk/media/for-organisatio..., page 6 and 7
[3] https://www.clinicaltrialsregister.eu/
[4] https://ico.org.uk/media/for-organisatio..., page 5

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer. We endeavour to
respond to requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

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Stevan Cirkovic

Dear Medicines and Healthcare products Regulatory Agency,

I have not heard back from you regarding my request to conduct an internal review on 7 May 2016. Please pass this on to the person who conducts Freedom of Information reviews.

I have requested an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Basic information on Clinical Trials approved in period of 2010-2016'.

In my letter dated from the 7th May, I have outlined why I think this is necessary. A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/b...

Please note that this is not a new/ original request for an internal review. So if I do not hear back from you in a non-automated reply within 7 days, I will lodge a formal complaint with the Information Commissioner.

Yours faithfully,

Stevan Cirkovic

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer. We endeavour to
respond to requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

2 Attachments

Dear Stevan Cirkovic,

 

Thank you for your email of 7 May 2016 asking the Agency to conduct an
internal review of our response to your Freedom of Information (FOI)
request and for your follow-up email of 14 June 2016.    

 

Please find attached the internal review. Please also find attached the
information requested in a spreadsheet format for your convenience, as per
the findings of our internal review.

 

Please note that, unfortunately, not all the data points in the ‘trial
status’ fields were retrievable when obtaining the data in this format. If
required, these will need to be obtained by going into the individual
listings but this is much more accessible than before. We hope this is
agreeable to you.

 

Please note the following:

 

-The information obtained from the EudraCT data warehouse relies on
decisions being entered by the national competent authority.

-The information obtained from the EudraCT data warehouse is based on what
applicant enters in their application form (‘Annex I’ form).

-The information provided does not reflect Phase I trials which are
commercially confidential and so exempt under Section 41 (Information
provided in confidence) and Section 43 (Commercial interests) of the FOI
Act. Section 41 is an absolute exemption and no consideration of the
public interest in necessary. Section 43 is a qualified exemption and a
consideration of the public interest should be made. We have considered
the public interest and cannot see any overriding argument for releasing
the information that outweighs the commercial harm by providing potential
competitors with an insight into the product development and design of
this study.

 

 

Yours Sincerely,

 

Customer Services

Communications division

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [1][MHRA request email]
Stay connected: [2]mhra.gov.uk/stayconnected

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