651 - If I have two clinical trials in slightly different patient populations, is it acceptable to present data from only one of the trials in an APS? Both populations fall under the same indication.
Jennifer Carroll last edited by
The most relevant principles here appear to be that data presentations in advertising must be consistent with the TMA (s3.1), must not be overly-selective (s5.12), and must consider all relevant data (s. 5.5.i).
Assuming both studies can be used in drug advertising (e.g. on-label, high-quality, etc.), you’d need to consider whether presenting data from only one study would be overly-selective (or misleading in some other way). This could potentially depend on many factors. For example, the degree of similarity between the populations, the extent to which the outcome in question differs between both studies, the degree of consistency with outcomes in the TMA, …etc.
If an HCP who modifies her behaviour/attitude based on something learned from an APS about study A is likely to feel misled after later learning about study B, the APS likely requires inclusion of study B so as not to be overly-selective.