Navigation

    Forum

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

    674 - Is it acceptable to compare the clinical trial inclusion/exclusion criteria among competitor products? We would like to make the point that patients with certain conditions were included in the trials for 1 product but not in trials for its competitors. I understand non-clinical information can be compared across products, and we wondered if inclusion/exclusion info was considered clinical or non-clinical. Could this be done in a branded context?

    Claims & Support/References for Claims
    1
    1
    87
    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

      No. Clinical trials are conducted to measure efficacy and safety. The described presentation would imply an indirect cross-product comparison of the populations in which efficacy / safety was demonstrated. This would contravene section 5.7 of the PAAB code.

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