Pivotal Trial Reprints on Branded Product Website
Re: 336 - The data appearing in a product monograph is based on a pivotal trial. The same study also discusses 'off-label' endpoints. Can reps distribute the reprint of the study to support data that is in the PM?
Another question similar to #336, would it be acceptable for the full, unedited, and peer reviewed pivotal trial reprint (trial in the clinical trial section of the PM) to be available in the resources section of a branded product website?
@virginieb I should clarify that this would be placed on the HCP gated website.
Jennifer Carroll last edited by
There are many considerations which would be assessed during the review process to determine whether this would be acceptable, but in general, the reprint of a PM study that is unedited and complete could be an acceptable downloadable resource on a gated HCP website. It should be disclosed where it will be placed and how it will appear (e.g. Study name? Description? Image?). This would be done as part of the review of the website to ensure that where it is placed for download is acceptable. Just one example of where it would not be acceptable: if the PM only included results of an interim analysis for an NOC/c product, we would question reprints of the final analysis even if they included the interim analysis results as NOC/c products are restricted to presentation of data from the PM only.