Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
PAAB Code - Post hoc analysis
-
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.
