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04 June 2018

The Kaplan-Meier plots from some (but not all) recent trials of immunotherapy versus chemotherapy have shown a delayed separation of survival curves. When considering design options for a new study of this type, there is a concern that the standard proportional hazards assumption will lead to an inappropriate design with a high risk of type II error. The first part of my talk will consider sensible choices of stopping boundary in this situation. 

 An alternative approach would be to assess the evidence for delayed separation, directly, at an interim analysis, and use this information to adapt the design. I will examine whether such an adaptive strategy leads to real gains compared to a fixed group-sequential trial.

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