Selection of the efficacy endpoint must be consistent with the trial objective.

Evaluation of the appropriateness of efficacy endpoint shall depend on the trial objective and the stage of development. If the trial is the pivotal study, the efficacy endpoint shall mainly be clinical outcomes (e.g. the overall survival, the degree of improvement in physiological functions, or the main symptoms of a disease), but in the absence of appropriate clinical endpoints, a clinically meaningful and  acceptable surrogate endpoint can be selected (for example: tumor response rate, laboratory data, or biomarkers).If this trial is an exploratory phase II clinical trial, a surrogate endpoint may be selected. However, whether the surrogate endpoint is appropriate needs to be carefully evaluated with the thinking from the perspective of pathophysiology and based on clinical data.

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