Pivotal Trial Reprints on Branded Product Website
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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?
Thank you! -
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?
Thank you! -
@virginieb I should clarify that this would be placed on the HCP gated website.
Hi @virginieb
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.
