417 - Hi Patrick, Can a company position its brand (from both a creative and messaging standpoint) on secondary outcomes in its PM? If not, then what code number does this contravene?
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There are a multitude of statistical and qualitative reasons to generally tread lightly with secondary endpoints. Nonetheless, it is sometimes possible for a secondary endpoint to be emphasized as the key creative in an APS depending on factors relating to the study, the particular endpoint, and the TMA. It is not possible to list all potential scenarios in which this is acceptable and unacceptable. Seeking a written opinion from PAAB (see the fee schedule on our website) is likely a good starting point when attempting this to ensure that you are walking down a productive path. Some reasons I've encountered over the past few months for which it has not been acceptable to focus on the secondary endpoint from the PM include (PAAB s3):· The secondary endpoint was only accepted in the context of the primary endpoint (e.g. for clarity, to avoid over-selectivity, or because the primary endpoint was directionally different)· Emphasis on this particular secondary endpoint (rather to some other secondary endpoint) was overly-selective· The endpoint extends beyond the indication· the study is located somewhere in the PM other than the clinical trial section of the PM (e.g. in the pharmacology section of the PM)· The endpoint is particularly sensitive to type I error and this wasn’t controlled in some way· There is also an important limitation in the TMA relating to this particular endpoint· There is no statistical analysis done with this endpoint.
