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The development of personalised (stratified) medicine is intrinsically dependent on an understanding of treatment-effect mechanisms (effects on therapeutic targets that mediate the effect of the treatment on clinical outcomes). There is a need for clinical trial data for the joint evaluation of treatment efficacy, the utility of predictive markers as indicators of treatment efficacy, and the mediational mechanisms proposed as the explanation of these effects.

Integrating biomarker information within trials to evaluate treatment mechanisms and efficacy for personalised medicine