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  3. Exploratory endpoints
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Exploratory endpoints

Scheduled Pinned Locked Moved PAAB Q&A
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  • U Offline
    U Offline
    Username
    wrote on last edited by
    #1

    Is it permissible to include mention of exploratory endpoints in a description of a study design, if the endpoint is not included in the PM? No results would be presented in the piece. Does the design of the study affect the permissibility (open-label vs. double-blind, single-arm vs. placebo-controlled)?

    Jennifer CarrollJ 1 Reply Last reply
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    • U Username

      Is it permissible to include mention of exploratory endpoints in a description of a study design, if the endpoint is not included in the PM? No results would be presented in the piece. Does the design of the study affect the permissibility (open-label vs. double-blind, single-arm vs. placebo-controlled)?

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hello @username
      If the endpoint in the study is one that would not be acceptable for presentation within the piece (such as an exploratory endpoint), it would not be acceptable to mention, even in a claim neutral manner, regardless of whether the study was open-label, double blinded, single-arm, or placebo-controlled.

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