EVIDENCE required; What has your organistion done to protect those volunteers engaged in UK drug trials?

Response to this request is long overdue. By law, under all circumstances, Medicines and Healthcare Products Regulatory Agency should have responded by now (details). You can complain by requesting an internal review.

Dear Medicines and Healthcare products Regulatory Agency,

Yesterday I was informed that there is no agency in this country which has the authority to check and monitor the data on how drug trial volunteers are treated in the UK.

My enquires have led to a Venn Diagram of cover ups.

The concern is that these drug trial centres seem to be based around Universities which in turn have Vice Chancellors and members of their Executive Boards who have had a career or strong links to pharmaceutical industries.

Even the top of the NHS Complaints system is headed by a board of staff who worked for a major drug company.

My enquires after 14 months suggest an odour of corruption within the NHS and student campus of major universities in the UK

Yours faithfully,

Fiona Watts

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 all requests within the Department of Health’s target response
time of 18 working days.
 
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.
 
***Please note that the agency is closed on Monday 25 and Tuesday 26 May
2015.***
 
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

Dear Ms Watts,

Thank you for your email which has been referred to our experts for consideration; we will respond to you as soon as possible.
The reference number for your enquiry is GCEP-00104131; please quote this number in any future correspondence on this matter.
Our maximum response time is 18 working days, but the vast majority of our enquiries are responded to before this time.

Kind Regards

Yvonne Smith
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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Clinical Trial Helpline, Medicines and Healthcare Products Regulatory Agency

 
Dear Fiona,
 
Thank you for your query.
 
Following the implementation of the Clinical Trials Directive 2001/20/EC
on 1 May 2004, compliance with the principles of GCP became a legal
requirement for everyone in the European Union involved in the conduct of
a clinical trial with an investigational medicinal product. Compliance
with GCP provides assurance that the rights, safety and well-being of
trial subjects are protected and that the results of the clinical trials
are credible and accurate. The Clinical Trials Directive was transposed
into UK law by the publication of The Medicines for Human Use (Clinical
Trials) Regulations 2004, Statutory Instrument No. 1031.
 
This Statutory Instrument and its subsequent amendments sets out the
requirements by which trials are approved by the MHRA (the UK Competent
Authority) and the Health Research Authority (parent organisation of the
National Research Ethics Service); and sets out the requirements by which
trials must be conducted and are regulated (including the basis for
inspection and enforcement).
 
The function of the MHRA GCP Inspectorate is to assess the compliance of
organisations with UK and EU legislation relating to the conduct of
conduct clinical trials of investigational medicinal products as part of
the MHRA's mission to safeguard public health.
 
Further information on the work of the MHRA can be found here:
 
[1]icineshttps://www.gov.uk/government/collection...
 
[2]https://www.gov.uk/good-clinical-practic...
 
 
Further information on the work of HRA and NRES can be found here:
 
[3]http://www.hra.nhs.uk/about-the-hra/our-...
 
Kind Regards
Clinical Trials Helpline
MHRA
 
Your views matter. Please tell us what you think of the service you have
received from us by following the link below:
[4]https://www.surveymonkey.com/s/ClinicalT...
 

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Ms Fiona Watts,

We apologise that you have not yet received a response.

Please accept this email as confirmation that we are chasing this matter up for you and we will respond as soon as possible.

Kind Regards,

Peter Onen (Mr)
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

Your views matter. Tell us what you think of the service you have received from us by following the link below:
https://www.surveymonkey.com/s/MHRACusto...

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Dear MHRA Customer Services,

The state of my health and abilities are evident in the poor spelling demonstrated by me on here.

The delays and lack of transparency are not in my best interests.

Yours sincerely,

Fiona Watts

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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