Adaptive Designs for Clinical Trials with a Time to Event Endpoint

What is it about?

Adaptive clinical trials are becoming increasingly accepted so long as appropriate methods to control the type I error rate are applied. For the important case of time to event data we show that the corresponding adaptive tests may ignore a substantial subset of the observed event times and derive an alternative test incorporating all event times where a conservative assumption must be made in order to guarantee type I error control.

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Why is it important?

Clinical Trials in Oncology are a major field of application for Adaptive Designs. Because these trials typically use time to event endpoints as Overall Survival or Progression Free Survival valid adaptive statistical tests in this setting are needed.