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Re: Chiugray post# 809889

Saturday, 01/17/2026 12:19:33 AM

Saturday, January 17, 2026 12:19:33 AM

Post# of 823449
NWBO Near Post-Hoc Addition of the ECA Violates the Guidance of the MHRA:
#27: "Without sufficient pre-specification there could be issues related to multiplicity. For example, if
a trial is analysed without an external control, and after the analysis an external control is
added, this may inflate type I error if it is not clear which was the primary analysis. Therefore,
it must be clear what the pre-specified primary analysis for the trial is."
https://assets.publishing.service.gov.uk/media/6825bab1a4c1a40fde4e63e5/Draft_MHRA_Guideline_on_Studies_with_RWD_ECA_May2025.pdf
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