Unpublished extension data
-
Hello,
My client has extension data (not yet published) from one of their pivotal trials. The interim results from the pivotal trial are in the Product Monograph. They would like to use the extension data in promotional pieces, but is there any way to do this if the actual data hasn't been published yet? If the data is soon to be published, would a letter from the publisher confirming upcoming publication suffice?
-
Hello @jdilly11
PAAB code section 3.1.1 requires that clinical claims are based on published, peer-reviewed, controlled and well-designed studies with clinical and statistical significance clearly indicated. Unpublished data would not be considered sufficient. If a study has been accepted for publication and completed the peer-review process (i.e. final manuscript is approved and awaiting official publication), PAAB can accept a letter from the editor confirming the future publication of the manuscript as presented in the submission.
