Groups: (Hardly‽) overlapping CIs [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2024-11-21 14:20 (559 d 14:08 ago) – Posting: # 24286
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Hi BEQool,

an example. Study powered to 90%, n=65, n1=31, n2=34, groups separated by 1 (one!) day. Eva­lu­a­tion per protocol with group model II. Cmax and AUC passed with ease. A deficiency letter one week before M13A was published:

Due to the significant Group × Formulation effect (p<0.05) for ln-transformed Cmax observed in model I, a separate exploratory analysis of each group was performed and produced the following outcomes:

Group 1: The 90% CI for Cmax (108.5–126.38%) fell outside the bioequivalence limits, while the CI for AUC (99.31–117.47%) remained within the limits.
Group 2: Both the 90% CIs for Cmax (90.01–109.2%) and AUC (85.43–106.39%) fell within the bioequivalence limits.

The finding from model I suggests heterogeneity of treatment effect across groups, with 90% CIs for Cmax hardly overlapped as demonstrated with model III submitted by the applicant. Therefore, the applicant should provide a justification for this difference and discuss its potential impact on the conclusion of bioequivalence.


A new term: Hardly overlapping CIs. Again: So what? Justification?
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