| 摘要(英) |
The main objective of this study is to delve into the performance of net effect and fraction effect in three-arm non-inferiority trials, and to determine the required sample size to ensure that Type I error and power reach the expected levels. Three-arm non-inferiority trials, encompass experimental, control, and placebo arms, aiding in a more comprehensive evaluation of the efficacy of new drugs. In this study, we consider the primary endpoint as right-censored survival data, including administrative censoring and loss to follow-up censoring. In terms of modeling, we employ three semi-parametric models, namely the Cox proportional hazards model, Accelerated Failure Time (AFT) model, and Proportional Odds (PO) model, conducting various analyses to determine the optimal sample size for each model under different allocation ratios. Ultimately, we apply the findings of the study to real data on bladder cancer recurrence, calculating the required sample sizes for each group under different scenarios. |
| 參考文獻 |
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至系統瀏覽論文 (2027-7-1以後開放)
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