Saturday, June 28, 2025 1:20:38 PM
The MHRA guidance is clearly for lethal diseases, which GBM is due to its low survival rate. Question why do you keep insisting that patients die in the control arm so that they can be compared to treatment? Are you a member of some kind of death cult or something? Seriously its not healthy.
Anyway if you hate it that MHRA has become ethical by all means, take it up with them, let me help you:
https://www.gov.uk/government/consultations/mhra-draft-guideline-on-the-use-of-external-control-arms-based-on-real-world-data-to-support-regulatory-decisions
MHRA comments for stakeholder consultation on draft guideline on the use of ECA based on RWD to support regulatory decisions https://assets.publishing.service.gov.uk/media/6825ba07a4c1a40fde4e63e2/MHRA_comments_for_stakeholder_consultation_on_draft_guideline_on_the_use_of_ECA_based_on_RWD_to_support_regulatory_decisions.xlsx
Anyway if you hate it that MHRA has become ethical by all means, take it up with them, let me help you:
https://www.gov.uk/government/consultations/mhra-draft-guideline-on-the-use-of-external-control-arms-based-on-real-world-data-to-support-regulatory-decisions
MHRA comments for stakeholder consultation on draft guideline on the use of ECA based on RWD to support regulatory decisions https://assets.publishing.service.gov.uk/media/6825ba07a4c1a40fde4e63e2/MHRA_comments_for_stakeholder_consultation_on_draft_guideline_on_the_use_of_ECA_based_on_RWD_to_support_regulatory_decisions.xlsx
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