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Re: kgromax post# 228786

Tuesday, 01/09/2024 9:19:21 AM

Tuesday, January 09, 2024 9:19:21 AM

Post# of 232957
LOL! Dang kgro, says here regulators discourage that mITT (modified intention to treat) nonsense.

In rare circumstances it is acceptable for a modified ITT population, or mITT population to be used in place of the true ITT population. This can be defined in various ways; often the definition is ‘all randomised patients who received study treatment’. This is discouraged by regulators, however, and a full justification is required if the full ITT is not used for the primary inferences. Further reading of the ICH Statistical Principles For Clinical Trials E9 (found here) is recommended whenever considering a modified ITT population.
https://www.quantics.co.uk/blog/what-is-an-itt-or-intention-to-treat-population-in-a-clinical-trial/


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