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Group sequential tests when the primary endpoint is a delayed response

Lisa Hampson (University of Bath)
22/01/08

Group sequential tests propose that the data accumulated continuously throughout the course of a clinical trial or epidemiological study are analysed after each group of subjects has been observed. There are both ethical and economic advantages associated with sequential monitoring. Current group sequential designs assume that the primary response from each patient is available immediately after the treatment has been administered. In practice however, a delay is inherent in many endpoints where the response can only be measured after an extended observation period has elapsed. In this talk we explain how we can change the structure of a GST to formulate an efficient and systematic approach to handling delayed data in a sequential setting. Using Bayesian sequential decision theory and dynamic linear programming, we find tests which are optimal in the sense that they minimise, under certain scenarios, the expected number of subjects recruited on termination of a trial and conclude that for sufficiently small delays there are certainly good efficiency gains to be made from using GSTs.
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