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Quantifying the totality of treatment effect with multiple event-time observations in the presence of a terminal event from a comparative clinical study.


ABSTRACT: To evaluate the totality of one treatment's benefit/risk profile relative to an alternative treatment via a longitudinal comparative clinical study, the timing and occurrence of multiple clinical events are typically collected during the patient's follow-up. These multiple observations reflect the patient's disease progression/burden over time. The standard practice is to create a composite endpoint from the multiple outcomes, the timing of the occurrence of the first clinical event, to evaluate the treatment via the standard survival analysis techniques. By ignoring all events after the composite outcome, this type of assessment may not be ideal. Various parametric or semiparametric procedures have been extensively discussed in the literature for the purposes of analyzing multiple event-t

SUBMITTER: Claggett B 

PROVIDER: S-EPMC7021204 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature