581 - For an efficacy claim, comparing head-to-head results of the study drug vs. the standard treatment, what support is required to justify the claim "significant"?

  • For “statistically significant” you need a statistically significant p-value or CI. On occasion, multiplicity adjustments are required to control for type I error.
    For “clinically significant” you’d need the study to have predefined a threshold difference that is deemed to be “clinically significant”. The message “significant” on it’s own is ambiguous, “statistically” or “clinically” should be added as supported.

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