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M

msargeant

@msargeant
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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  • PAAB Code - Post hoc analysis
    M msargeant

    Hello!

    According to PAAB code 3 Making Statements: Claims, Quotes & References | 3.1.1:

    “Clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, are generally regarded as not being acceptable evidence in drug advertising. Data included in the TMA may be acceptable. Additionally, high quality meta-analysis and observational studies may be acceptable. Non-clinical claims must be well supported by relevant evidence.”

    Can you please advise when/ in what circumstances a post-hoc analysis would be considered acceptable?

    Appreciate any insights/guidance that can be shared.

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