PAAB Code - Post hoc analysis
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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.
-
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.
Hello @msargeant
Apologies for not seeing this question sooner. Per 3.1.1, post-hoc analysis are generally not considered acceptable evidence at this time. The circumstance in which post-hoc analyses would be considered acceptable is outlined in the statement that follows that copy which states “Data included in the TMA may be acceptable”. HTH.
