I noticed that in June 2019 there were discussions re a Real World Evidence Update and for a proposed RWE code change. Currently what is the code regarding the use of RWE?
Jennifer Carroll last edited by
Good Morning @donna
The proposed change did not go forward. Although these were intended as the beginning of an incremental process of change, following consultation it became clear that the industry felt that the guidance did not go far enough. We are therefore awaiting preliminary output from the ongoing Health Canada and CADTH collaboration on decision-grade RWE. An expert stakeholder committee will work through that output to determine which elements are applicable to drug advertising.
As a courtesy, the document Guidance on Observational Studies continues to inform on acceptable uses of observational studies in drug advertising.