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Fig. 4 | Journal for ImmunoTherapy of Cancer

Fig. 4

From: Validation of biomarkers to predict response to immunotherapy in cancer: Volume II — clinical validation and regulatory considerations

Fig. 4

There are three basic phase III design options for assessing the ability of a biomarker. The enrichment design includes only patients who are positive for the biomarker in a study evaluating the effect of a new therapy (1). In the biomarker stratified design, all patients, independent of biomarker results, are enrolled and randomized to treatment and control groups within each of the biomarker positive and negative groups to ensure balance (2). Finally, in the strategy design, patients are randomized between no use of the biomarker (all patients receive standard therapy on that arm) and a biomarker-based strategy where biomarker-negative patients receive standard therapy and biomarker-positive patients receive the new therapy (3)

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