Consideration Point 1

If profiles are blinded and clearly referred to as hypothetical, endpoints used do not have to match actual clinical trial data for a product. This is because the purpose of the profile is to gauge reactions for insights purposes and we are not providing promotional product information (where the data needs to be fully accurate and referenced). However, care should be taken that product profiles or hypothetical situations presented do not create unfounded hopes for new treatments, will not be perceived to influence a physician’s perception of the efficacy/safety profile of future treatments beyond reasonable bounds, or test claims that would never be feasible for a product.

Consideration Point 2

Real clinical trial data and endpoints can be used in a product profile both pre- and post-launch (e.g. if understanding reactions to specific endpoints to support marketing campaigns is the purpose of the research)

If real clinical trial data is used there is a risk that physicians might recognise the product being discussed due to knowledge of clinical trial publications or presentations, and therefore the research could be perceived as disguised promotion. In this case, extra care should be taken to avoid the perception of disguised promotion, such as clearly stating the purpose of showing the profile, blinding the product, and highlighting that there is no intention of influencing a physician’s opinion of actual available products when sharing the profile.

The questions asked concerning the profile (when real clinical trial data is used) should be treated with additional care for the same reasons as above.

Consideration Point 3

If real endpoints are used, this does not necessarily mean that the data needs to be referenced. Referencing clinical trial publications could increase the risk of unblinding a profile and therefore the risk that the data shown could be perceived as disguised promotion. If the profile is unblinded, referencing may be appropriate to ensure the data shown is perceived as transparent and balanced