CHMP backs new dose-finding approach

EMA's CHMP said a statistical and modeling methodology proposed by Novartis AG (NYSE:NVS; SIX:NOVN) could improve the analysis of Phase II dose-finding trials. Typically, sponsors perform pairwise comparisons of data from different doses to establish significance and select doses for Phase III testing based on a sigmoidal curve. Novartis' proposed approach involves prespecifying three to seven dose-response models based on factors that could include disease biology, the target and the molecular mechanism of action. In this approach, proof of efficacy would be based on an adequate fit to one model, which would then used to select doses for Phase III studies. ...