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 Carroll last edited by
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.