Are Statistical Analysis Plans “required” for Pivotal Studies? [General Sta­tis­tics]

posted by Achievwin – US, 2023-02-15 13:07 (109 d 14:17 ago) – Posting: # 23467
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❝ Dear colleagues, we are conducting a pivotal fed-fasted BE study versus a reference listed drug (RLD).

Here is my opinion:

Essentially it is your study and you have to defend the submission, it is your prerogative to have what you want. - CRO gets most of their money when they deliver draft report (study pass/fail)

If it is a complex study - you have to predefine critical steps in the SAP (before the sample analysis start- to avoid any claims of Bias).

If it is a study against the product specific guidance and logical analysis is easy to understand you can refer to the FDA guidance(s) in the protocol.

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