Navigation

    Forum

    • Register
    • Login
    • Search
    • Categories
    • Recent
    • Popular
    • Users
    • Groups

    611 - Section 3.1.10 of the Code states that "Secondary endpoints should be identified as such and the primary endpoint of the study should be presented in close proximity when warranted." How do you know when presentation of the primary endpoint is warranted? Is it always necessary to present the primary endpoint when presenting data (i.e., a secondary endpoint) that is in the product monograph?

    Claims & Support/References for Claims
    1
    1
    136
    Loading More Posts
    • Oldest to Newest
    • Newest to Oldest
    • Most Votes
    Reply
    • Reply as topic
    Log in to reply
    This topic has been deleted. Only users with topic management privileges can see it.
    • Jennifer Carroll
      Jennifer Carroll last edited by

      It is not always necessary (although it is often necessary). The primary endpoint is required to appear prior to the secondary endpoint when not doing so could mislead the audience in some way. There would be several circumstances in which that could be the case but I’ll present one scenario here to make the point. Let’s say, for example, that non-inferiority versus the active comparator was demonstrated on the primary endpoint in a pivotal trial which is included within the product monograph. It would be misleading to present product monograph superiority data for a secondary endpoint from that same pivotal study without first conveying the fact that the product was non-inferior in the primary outcome. Although, secondary endpoints which are not directionally consistent with the primary endpoint are generally not accepted, the presentation would be acceptable in this case as it is consistent with the product monograph.

      1 Reply Last reply Reply Quote 0
      • First post
        Last post