Regarding the use of PROs in promotional materials:
In cases where a PRO is not contained in the TMA and is not the primary endpoint (but is a reliable and valid pre-defined endpoint and is consistent with the primary endpoint), does the PRO need to be designated as a key secondary outcome in order to be included in promotional materials? Additionally, generally speaking, under what circumstances would the disclosure of other failed secondary endpoints be required?
Jennifer Carroll last edited by
The document Guidance on Patient Reported Outcomes provides the limitations for use of PROs. It is not required that the study identifies it as a “key” secondary endpoint. Note that it must be identified as a “secondary endpoint” and this must be disclosed in the APS per code section 3.1.10.
The discloser of failed secondary endpoints is required when they are closely related to the other endpoints so as not to be selective. (s.5.12)