Optimal Futility Interim Design: A Predictive Probability of Success Approach with Time-to-Event Endpoint.
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.
a Novartis , East Hanover , New Jersey , USA.
Zhongwen
Z
Tang
D000465:Algorithms; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D003198:Computer Simulation; D018572:Disease-Free Survival; D023381:Endpoint Determination / Q000706:statistics & numerical data*; D006801:Humans; D018447:Medical Futility; D011237:Predictive Value of Tests; D011336:Probability; D012107:Research Design / Q000706:statistics & numerical data*; D035501:Uncertainty
Decision-making; Inverse normal test statistic; Optimal design; Predictive probability of success; Time-to-event.