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首页> 外文期刊>BMC Medical Research Methodology >Including non-concurrent control patients in the analysis of platform trials: is it worth it?
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Including non-concurrent control patients in the analysis of platform trials: is it worth it?

机译：包括非并发控制患者在分析平台试验中：值得吗？

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摘要

Platform trials allow adding new experimental treatments to an on-going trial. This feature is attractive to practitioners due to improved efficiency. Nevertheless, the operating characteristics of a trial that adds arms have not been well-studied. One controversy is whether just the concurrent control data (i.e. of patients who are recruited after a new arm is added) should be used in the analysis of the newly added treatment(s), or all control data (i.e. non-concurrent and concurrent). We investigate the benefits and drawbacks of using non-concurrent control data within a two-stage setting. We perform simulation studies to explore the impact of a linear and a step trend on the inference of the trial. We compare several analysis approaches when one includes all the control data or only concurrent control data in the analysis of the newly added treatment. When there is a positive trend and all the control data are used, the marginal power of rejecting the corresponding hypothesis and the type one error rate can be higher than the nominal value. A model-based approach adjusting for a stage effect is equivalent to using concurrent control data; an adjustment with a linear term may not guarantee valid inference when there is a non-linear trend. If strict error rate control is required then non-concurrent control data should not be used; otherwise it may be beneficial if the trend is sufficiently small. On the other hand, the root mean squared error of the estimated treatment effect can be improved through using non-concurrent control data.
机译：平台试验允许向正在进行的试验中添加新的实验治疗方法。由于提高了效率，此功能对从业者对从业者具有吸引力。然而，增加武器的试验的经营特征尚未得到很好地研究。一项争议是，应该在新添加的治疗或所有控制数据（即不同时和并发）的分析中使用并发控制数据（即，添加新手臂后的患者的患者的患者吗？ 。我们调查在两阶段设置内使用非并发控制数据的益处和缺点。我们进行仿真研究，以探讨线性的影响和步骤趋势对试验的推断。当其中包括所有控制数据或仅在分析新添加的处理时，我们比较几种分析方法。当存在正趋势并且使用所有控制数据时，拒绝相应假设的边缘功率和一个错误率可以高于标称值。基于模型的方法调整阶段效果相当于使用并发控制数据;当存在非线性趋势时，具有线性术语的调整可能无法保证有效推理。如果需要严格的错误率控制，则不应使用非并发控制数据;否则，如果趋势足够小，可能是有益的。另一方面，可以通过使用非并发控制数据来提高估计治疗效果的根平均平方误差。

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