Adaptive design simulations and sample size

Evaluate power error and feasibility

Simulate the complete stopping and adaptation process under null, alternative and operational scenarios. Report Monte Carlo uncertainty along with error rates, power, bias and coverage.

Flow diagram

Steps

Define candidate adaptive designs

Specify objectives, decision rules and maximum information or sample size.

Define null and alternative scenarios

Vary effect, nuisance parameters, accrual, delay and missingness.

Simulate the full decision process

Include interim timing, permitted actions and final analysis methods.

Assess operating characteristics

Assess type I error or relevant Bayesian decision properties, power, sample size, bias and interval coverage. Quantify Monte Carlo uncertainty from independent simulated trial replicates.

Document reproducible evidence

Record software, code version, seeds, Monte Carlo uncertainty and review decisions.