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Published on: October 23, 2020
Optimal Futility Interim Design: A Predictive Probability of Success Approach with Time-to-Event Endpoint
1a Novartis , East Hanover , New Jersey , USA.
Abstract:
An analytical way to compute predictive probability of success (PPOS) together with credible interval at interim analysis (IA) is developed for big clinical trials with time-to-event endpoints. The method takes account of the fixed data up to IA, the amount of uncertainty in future data, and uncertainty about parameters. Predictive power is a special type of PPOS. The result is confirmed by simulation. An optimal design is proposed by finding optimal combination of analysis time and futility cutoff based on some PPOS criteria.
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