Inference for Cumulative Incidences and Treatment Effects in Randomized Controlled Trials with Time-to-Event Outcomes under ICH E9 (R1)
ICH E9(R1)框架下随机试验累积发生率与处理效应的推断
In randomized controlled trials (RCTs) that focus on time-to-event outcomes, intercurrent events can arise in two ways: as semi-competing events, which modify the hazard of the primary outcome events, or as competing events, which make the definition of the primary outcome events unclear. Although five strategies have been proposed in the ICH E9 (R1) addendum to address intercurrent events in RCTs, these strategies are not easily applicable to time-to-event outcomes when…