篮子试验是一种临床试验类型，其资格主要基于不同癌症类型亚群中的特定分子特征存在性。现有的基于贝叶斯层次模型的篮子设计往往改善了评估治疗效果的效率；但是，这些模型根据在不同选择情况下模拟研究的结果校准了第一类错误率。家族内错误率的理论控制对于决策药物批准非常重要。在本研究中，我们提出了一种新的基于贝叶斯二阶段设计，一次中间分析用于在目标水平上控制FWER，以及第一类型和第二类型错误率的制定。由于第一类错误率理论制定的复杂性，我们设计了基于模拟的方法以近似第一类错误率。所提出的设计使在最终分析中调整截断值以控制FWER达到目标值成为可能。模拟研究证明，即使在不同亚群中招募的患者数量不同的情况下，所提出的设计仍可以用于控制近似FWER低于目标值。招募的患者数量有时无法达到预定值，因此既有的篮子设计可能无法在开始试验前确保定义的操作特性。基于最终分析结果调整截断值以控制FWER达到目标值的所提出的设计将是更好的选择。© 2023年。作者。

A basket trial is a type of clinical trial in which eligibility is based on the presence of specific molecular characteristics across subpopulations with different cancer types. The existing basket designs with Bayesian hierarchical models often improve the efficiency of evaluating therapeutic effects; however, these models calibrate the type I error rate based on the results of simulation studies under various selected scenarios. The theoretical control of family-wise error rate (FWER) is important for decision-making regarding drug approval.In this study, we propose a new Bayesian two-stage design with one interim analysis for controlling FWER at the target level, along with the formulations of type I and II error rates. Since the difficulty lies in the complexity of the theoretical formulation of the type I error rate, we devised the simulation-based method to approximate the type I error rate.The proposed design enabled adjustment of the cutoff value to control the FWER at the target value in the final analysis. The simulation studies demonstrated that the proposed design can be used to control the well-approximated FWER below the target value even in situations where the number of enrolled patients differed among subpopulations.The accrual number of patients is sometimes unable to reach the pre-defined value; therefore, existing basket designs may not ensure defined operating characteristics before beginning the trial. The proposed design that enables adjustment of the cutoff value to control FWER at the target value based on the results in the final analysis would be a better alternative.© 2023. The Author(s).