UK clinical trials of investigative medicinal products
Dear Medicines and Healthcare products Regulatory Agency,
MHRA guidance published on 01 Sept 2020 for CTIMPs stated that:
"The time frame for publishing the summary of results is within 6 months of the end of trial for paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials. You should publish your summary results within these timeframes in the public register (or registers) where you have registered your clinical trial. You do not need to submit this clinical trial summary report to the MHRA as well; however, you must send a short confirmatory email to [email address] once the result-related information has been uploaded to the public register and provide a link."
https://www.gov.uk/guidance/registration...
Questions:
1. What follow-up action will the MHRA take when no confirmatory email has been received within the 12/6 month time frame set out in its guidance?
2. Will the MHRA proactively make public information on which trials have failed to make their results public in the public register(s) within the 12/6 month time frame set out in its guidance?
3. Will the MHRA impose sanctions on trial sponsors that fail to make their results public in a public register within the 12/6 month time frame set out in its guidance? If yes, please detail the criteria for imposing sanctions, and the nature of those sanctions. (Note: "Sanctions" in this context are to be understood broadly, and may include MHRA withholding of approval for new CTIMPs by sponsors who at the time are non-compliant with the guidance cited above.)
Yours faithfully,
Till Bruckner
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References
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Reference CSC 15516
Dear Mr Bruckner,
Thank you for your email dated 16 September 2020 regarding Freedom of Information request - UK clinical trials of investigative medicinal products.
We have reviewed your request and will need to redirect your query to Licensing Division for further input.
We aim to have a response to you within 5 working days.
In the meantime, should you have any other questions or requests please feel free to call us on 0203 080 6000 or email at [MHRA request email]
Our opening hours are Mon – Fri 9 am to 5 pm (excluding UK Public Holidays)
Kind regards
Yvonne
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data protection rights, please see our three centres’ Privacy Notices: MHRA, CPRD and NIBSC.
Your views matter. Tell us what you think of the service you have received from us by following the link below:
https://www.surveymonkey.co.uk/r/SK859RP
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https://www.gov.uk/government/collection...
Reference CSC 15516
Dear Mr Bruckner,
Thank you for your email dated 16 September 2020 regarding Freedom of
Information request - UK clinical trials of investigative medicinal
products.
This has now been resolved by Licensing Division who have provided a full
response.
MHRA is working closely with the Health Research Authority (HRA) on
improving the transparency of clinical research in the UK. HRA has a
legal duty to promote research transparency and is taking a leading role
on behalf of the research system across the UK to champion openness and
drive improvements in performance. You will be aware that HRA recently
published their transparency strategy document "Make it Public:
transparency and openness in health and social care research".
To facilitate monitoring of publication of results, MHRA systems upgrades
over the past year means that individual cases raise a flag where no
record of results posting has been received in the expected timeframe
following notification of the end of trial. These cases will be
followed-up and our Good Clinical Practice (GCP) inspectorate colleagues
informed where a response is not forthcoming. HRA have also confirmed
that when appropriate data collection and monitoring systems are in place,
transparency performance in the research community will be published. Poor
performance will be highlighted by publishing transparency information
about individual sponsors.
Currently, we have no legislation that would allow us to issue sanctions
on sponsors. Our GCP inspectors will review compliance on inspection, as
they do currently. If issues are found on inspection, a finding is given,
and corrective and preventative action is required by the sponsor to
address the shortcoming; however, no enforcement action is available as
this is not an offence under the current legislation. A Bill is currently
going through parliament (the Medicines and Medical devices Bill) that
will allow us to update UK legislation to make new transparency provisions
as well as any appropriate sanctions for not complying with the new
legislation. Any changes will, of course, be made following consultation.
Should you require any further support please feel free to contact us on
0203 080 6000 or by email.
Our opening hours are Mon – Fri 9am to 5pm (excluding UK Public Holidays)
With regards
Yvonne
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
[1]gov.uk/mhra
[2]Stay connected
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: [3]MHRA,
[4]CPRD and [5]NIBSC.
Your views matter. Tell us what you think of the service you have received
from us by following the link below:
[6]https://www.surveymonkey.co.uk/r/SK859RP
Read our guidance on coronavirus (COVID19)
[7]https://www.gov.uk/government/collection...
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