802

A primary endpoint is stratified by multiple parameters, as stated in the TMA. Would it therefore be acceptable to include the subgroup analysis results for these parameters in advertising (Forest plot) from the published study, assuming they are statistically and directionally consistent with the overall primary endpoint result?

There are many considerations in the assessment of subgroup analysis for claims in advertising. See PAAB Guidance on Subgroup Analysis for more comprehensive guidance.

802

Laisser un commentaire

Votre adresse e-mail ne sera pas publiée.

dix − 8 =

Retour en haut