Article | September 27, 2022

How To Conduct Better Time-To-Event Analysis With Delayed Treatment Effects

Source: Cytel
Orphan Indications and Clinical Trials - Why Rare Diseases Warrant Special Treatment

The issue of delayed treatment effects in immuno-oncology was demonstrated during a FDA-Industry sponsored workshop over two years ago. This demonstration made it clear that traditional log-rank tests, often used for analyses of progression free survival and overall survival, would need to be replaced as essential assumptions of the test no longer held.

Cytel scientists along with colleagues at Pfizer, Merck, the Medical University of Vienna, Bath University and Harvard University, have recently proposed a new test in a study published in Biometrical Journal. The max-combo test enables analysis of PFS and OS when handling delayed treatment effects, while also adding the option for early stopping.

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