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Early-Phase Oncology Trials: Why So Many Designs?
Journal of Clinical Oncology ( IF 42.1 ) Pub Date : 2022-08-12 , DOI: 10.1200/jco.21.02493
Matthieu Clertant 1
Affiliation  

The past 30 years have seen a considerable effort on the part of statisticians to improve the design and accuracy of early-phase oncology trials. Some of this effort has been rewarded via successful implementation in actual trials, yet it would be fair to say that among clinicians, there remains some reluctance to fully embrace more efficient model-based approaches. One reason for such reticence is the difficulty in understanding exactly what is being offered by more modern designs. Although it is generally accepted that these designs offer improvements over the old standard 3 + 3 design, a new question has then to be addressed: How should we decide among the new proposals which one is the best for our purpose? In this study, we recall 15 designs that are currently proposed and in use. We show that among these 15 designs, many are operationally identical. These 15 designs reduce to three broad classes of designs. This review helps summarize their properties and differences and highlights that certain designs require ad hoc modifications to ensure satisfactory performance.



中文翻译:

早期肿瘤学试验:为什么有这么多设计?

在过去的 30 年里,统计学家为改进早期肿瘤学试验的设计和准确性做出了相当大的努力。通过在实际试验中的成功实施,其中一些努力得到了回报,但可以公平地说,在临床医生中,仍然有些人不愿意完全接受更有效的基于模型的方法。这种沉默的原因之一是难以准确理解更现代的设计所提供的内容。虽然人们普遍认为这些设计比旧标准 3 + 3 设计有所改进,但必须解决一个新问题:我们应该如何在新建议中决定哪一个最适合我们的目的?在这项研究中,我们回顾了 15 种目前提出并正在使用的设计。我们展示了在这 15 种设计中,许多在操作上是相同的。这 15 种设计可归结为三大类设计。这篇评论有助于总结它们的特性和差异,并强调某些设计需要特别修改以确保令人满意的性能。

更新日期:2022-08-13
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