Abstract:
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Healthcare providers and drug makers now have to deliver a compelling value proposition in oncology to stay relevant in an increasingly crowded market with multiple therapeutic options. This means a significant improvement in the risk-benefit ratio will become an even more critical decision driver in cancer care. In this context, a metric that looks at the 'net benefit' rather than the absolute benefit is very appealing to both patients and payers. One such metric is the 'treatment-free-interval (TFI)' which is generally defined as the time from discontinuation of treatment to the start of disease progression. Our computation of TFI is based on partitioned survival analysis and makes use of the mean time to events of interest. The application of this methodology to specific clinical trials often brings up analytical issues, some of which will be discussed, as they apply to a large phase 3 oncology study.
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