Secondary hierarchical endpoints
-
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)? -
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)?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.
-
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.
-
@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?
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.
