Proposed changes [Two-Stage / GS Designs]

posted by Mauricio Sampaio  – Brazil, 2020-02-17 12:50 (425 d 10:08 ago) – Posting: # 21177
Views: 3,453

» Consequences for the Consulta Pública N° 760.

Instead of: "Type I error must be preserved and adjusted, and to demonstrate bioequivalence the level of confidence is 94.12%;"

I will only propose that: It must be demonstrated that the type I error of the study is controlled.

Instead of: "This second group must have at least 50% of the previous group"

I will propose that: The number of participants in the second stage must be calculated based on the data extracted from the first stage. The calculation must be justified considering possible losses and / or dropouts observed in the first stage.

In this way, the dialogue is open and not restricted. = "on top of the wall"


Edit: Subject line changed; see also this post #2. [Helmut]

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