Comparison of Blinding Sample Size Adjustment with Unblinding One in Clinical Trials Through Simulations
10.3969/j.issn.1002-3674.2009.05.008
- VernacularTitle:自适应设计中盲态和揭盲状态样本量调整的模拟比较
- Author:
Suzhen WANG
;
Jielai XIA
;
Liang ZHENG
- Publication Type:Journal Article
- Keywords:
RCT;
Type I error inflation;
Adaptive de-sign;
Monte Carlo simulation
- From:
Chinese Journal of Health Statistics
2009;(5):477-479,482
- CountryChina
- Language:Chinese
-
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.
