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Abstract:
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Many clinical trials contain complex failure-time data. For example: 1) Multiple-type events, 2) Recurrent events, 3) Mixture of multiple-type events and recurrent events, 4) Single failure times on different subjects may be correlated, arising, for example, from genetic effects. Several models have been proposed such as the Anderson-Gill model, the PWP model (Prentice, William, and Peterson), the WLW model (Wei, Lin, and Weissfeld), the LWA model (Lee, Wei, and Amato), and a frailty model. However, multiple-event analysis is not often primarily considered in the design of clinical trial. During this group discussion, I would like to focus on the following types of data: a) multiple-type events; b) recurrent events; c) mixture of recurrent and multiple-type events and share experience with respect to analysis methods, study design consideration, interactions with regulatory agencies, and labeling negotiations.
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