Secondary hierarchical endpoints

[Username]

Hello,
If a pivotal trial has a secondary endpoint that is predefined and included in the trial description in the monograph, but the data is not included in the monograph due to a failed secondary endpoint higher up in the hierarchical testing structure, is it possible to present the data for this endpoint in a neutral way in an APS (knowing that significance could NOT be claimed for this endpoint)?

[Jennifer Carroll]

Hello @username

Listing the outcomes within the trial design in the TMA does not necessarily qualify it for discussion within a promotional tool. As a general rule of thumb, if there are no valid stats, there is no claim. Data for endpoints past the failed endpoint in hierarchical testing, should not be presented in advertising.

[Username]

@jennifer-carroll Thank you for your quick reply. Would it be acceptable to disclose this endpoint in an APS when discussing study design, as it would be consistent with the TMA?

[Jennifer Carroll]

Hey @username

In the context of a study design, with no additional weight that would emphasize the endpoint, it would likely be acceptable to mention the endpoint.