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

posted by Helmut Homepage – Vienna, Austria, 2024-11-22 13:58 (139 d 09:44 ago) – Posting: # 24292
Views: 2,287

Hi BEQool,

❝ […] Unfortunately, these kind of deficiency questions will probably become inevitable when conducting a study in groups.

Quite likely, esp. since agencies think that \(\small{p(G\times T)<0.05}\) is a signal of data manipulation.

❝ ❝ […] a separate exploratory analysis of each group was performed and produced the following outcomes

❝ Did you perform this exploratory analysis of each group or did the agency do it?

The applicant did.

❝ ❝ Therefore, the applicant should provide a justification for this difference and discuss its potential impact on the conclusion of bioequivalence.

↑ This was a request of the agency.

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

❝ How do you plan to "justify" this difference?

Well, the deadline for the response is today. I made only sarcastic comments like …

As long as confidence limits overlap, treatment effects estimated in the groups do not differ significantly. To question that is like saying “since the upper confidence limit is 124%, products are hardly bioequivalent”

… and suggested the applicant to translate it into a more diplomatic language.
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