Figure 5 Examples of biomarker-guided trials

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Presentation transcript:

Figure 5 Examples of biomarker-guided trials Figure 5 | Examples of biomarker-guided trials. When results of biomarker analysis are available before randomization, the next step is to consider whether a response to treatment is anticipated. If some efficacy is expected even in patients with negative biomarker results, all patients (stratified on the basis of biomarker results) are included for randomization (Trials 1 and 2). Otherwise, only participants with positive biomarkers are included in the randomization scheme (Trial 3). When biomarker results are not available before randomization (Trial 4), participants are first allocated to the treatment arms, and the biomarker assay is performed during the trial. In this case, the findings of the trial are analysed and stratified on the basis of the retrospective determination of biomarker positivity or negativity. Antman, E. M. & Loscalzo, J. (2016) Precision medicine in cardiology Nat. Rev. Cardiol. doi:10.1038/nrcardio.2016.101