Bayesian Phase II optimization for time-to-event data based on historical information.

After exploratory drug development, companies face the decision whether to initiate confirmatory trials based on limited efficacy information. This proof-of-concept decision is typically performed after a Phase II trial studying a novel treatment versus either placebo or an active comparator. The article aims to optimize the design of such a proof-of-concept trial with respect to decision making.

The predictive distribution of the residual variability in the linear-fixed effects model for clinical cross-over trials.

In the linear model for cross-over trials, with fixed subject effects and normal i.i.d.