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International society for clinical biostatistics

However, we find the title somewhat confusing. From it, one may get the impression that the document addresses meta-analysis versus one (pivotal) study (in a submission). However, this does not seem to be the case. The fact that ‘meta-analysis’ and ‘one pivotal study’ are addressed as separate topics should be borne out more clearly in the title. We suggest: “Points to consider on validity and interpretation of a meta-analysis and of a single pivotal study, respectively”.