Inclusion of trial patient characteristics within a Rep CVA
-
Are there rules around having to include a slide on the patient population characteristics from the trials within a Rep CVA? Is it acceptable to have this slide in an Appendix, so available if necessary?
-
Are there rules around having to include a slide on the patient population characteristics from the trials within a Rep CVA? Is it acceptable to have this slide in an Appendix, so available if necessary?
Hello @brendaarmit1
It’s difficult to answer this question as there are scenarios where the patient population characteristics would be required within the presentation and scenarios where it would not. As a general rule of thumb there is no requirement to include the full patient characteristic breakdown from a study however certain characteristics may be required to render the presentation complete. If there is a claim that would require the patient characteristics in order to allow for accurate interpretation of the copy, patient characteristics may be requested.
-
Hello @brendaarmit1
It’s difficult to answer this question as there are scenarios where the patient population characteristics would be required within the presentation and scenarios where it would not. As a general rule of thumb there is no requirement to include the full patient characteristic breakdown from a study however certain characteristics may be required to render the presentation complete. If there is a claim that would require the patient characteristics in order to allow for accurate interpretation of the copy, patient characteristics may be requested.
@jennifer-carroll Thanks for your direction on this. Just to confirm, if there is an instance where the patient characteristics are not required in order to interpret the copy, we don't need to include it on the slide. We can; however, create an appendix slide with patient characteristics just in case a Rep is asked by the HCP and it is available for them to use. Of course, this appendix slide will be reviewed by PAAB, but not required as part of the consecutive CVA presentation.
-
@jennifer-carroll Thanks for your direction on this. Just to confirm, if there is an instance where the patient characteristics are not required in order to interpret the copy, we don't need to include it on the slide. We can; however, create an appendix slide with patient characteristics just in case a Rep is asked by the HCP and it is available for them to use. Of course, this appendix slide will be reviewed by PAAB, but not required as part of the consecutive CVA presentation.
Hey @brendaarmit1
An appendix containing the patient characteristics would be assessed upon review of the CVA and if acceptable, could be included for reference purposes.
-
Hey @brendaarmit1
An appendix containing the patient characteristics would be assessed upon review of the CVA and if acceptable, could be included for reference purposes.
@jennifer-carroll Thank you!
