Comparison of Blinding Sample Size Adjustment with Unblinding One in Clinical Trials Through Simulations / 中国卫生统计

ABSTRACT

Objective To determine the appropriate methods to sample size adjustment for adaptive design through simulations by comparing sample size adjustment of blinding internal pilot design with that of unwinding one in clinical trials. Methods Compare type I error and the power of blinding and unblinding internal pilot design through Monte Carlo simulation. Results Either type I error rates or the powers are not substantially distinct in two lands of settings. Conclusion Blinding sample size adjustment is more preferable.