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.
Use of a MAIC study as a download in an APS
-
Would it be permissible to include a matching-adjusted indirect comparison (MAIC) study (between Product X and a competitor) as an attachment/download in an APS? Or would this type of publication automatically contravene PAAB code?
We note that 5.7.1 discusses how PAAB does not allow the use of PM-PM or study-study comparisons of efficacy and safety due to cross-trial differences. However, use of MAIC is shown to reduce or remove cross-trial differences.
-
Would it be permissible to include a matching-adjusted indirect comparison (MAIC) study (between Product X and a competitor) as an attachment/download in an APS? Or would this type of publication automatically contravene PAAB code?
We note that 5.7.1 discusses how PAAB does not allow the use of PM-PM or study-study comparisons of efficacy and safety due to cross-trial differences. However, use of MAIC is shown to reduce or remove cross-trial differences.
In general, PAAB code section 5.7 requires that comparisons between products be supported by randomized, controlled, head to head trials. As noted in your question, code section 5.7.1 further addresses across TMA or across different study comparisons, which are also not acceptable. Indirect comparisons pose challenges with unaccounted factors, potential estimations, etc, that may materially affect the results. As such, the PAAB Code and Health Canada guidance on therapeutic comparisons, require head to head trials as opposed to indirect comparisons. While we do not have the specific MAIC for review, an MAIC study does not meet code section 5.7 requirements and would not be acceptable in advertising. PAAB offers an opinion service should the sponsor wish to present their position on the merits of their specific study.
-
In general, PAAB code section 5.7 requires that comparisons between products be supported by randomized, controlled, head to head trials. As noted in your question, code section 5.7.1 further addresses across TMA or across different study comparisons, which are also not acceptable. Indirect comparisons pose challenges with unaccounted factors, potential estimations, etc, that may materially affect the results. As such, the PAAB Code and Health Canada guidance on therapeutic comparisons, require head to head trials as opposed to indirect comparisons. While we do not have the specific MAIC for review, an MAIC study does not meet code section 5.7 requirements and would not be acceptable in advertising. PAAB offers an opinion service should the sponsor wish to present their position on the merits of their specific study.
@jennifer-carroll Thank you for the clarification, Jennifer!
