Since the launch of their first trial in Acute myeloid leukaemia (AML) in 1959, the Medical Research Council (and latterly National Cancer Research Institute) has conducted randomised trials in AML uninterrupted for six decades. These sixty years have seen a transformation in the way we diagnose, characterise and treat the disease, (and indeed a sea change in clinical trial regulations) and a continuing improvement in outcomes. The increasing refinement of diagnosis, leading to the advent of tailored therapies, and the use of disease monitoring both have the potential to improve outcomes further, but the associated complexities will require an evolution in our approach to trial design. This article looks at the extent to which the guiding principles of the first AML trials remain relevant today, and the challenges facing the next generation of trials methodologists.

中文翻译：

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评估英国关于急性髓细胞性白血病的60年研究研究：过去，现在和将来的试验设计课程。

自1959年在急性髓细胞性白血病（AML）中首次开展试验以来，医学研究理事会（及其后的国家癌症研究所）已连续60年在AML中进行了不间断的随机试验。在这六十年中，我们诊断，表征和治疗该疾病的方式发生了变化（实际上临床试验法规发生了翻天覆地的变化），并且结果不断改善。诊断的不断完善，导致量身定制的治疗方法的出现，以及疾病监测的使用，都有可能进一步改善结果，但相关的复杂性将需要我们试验设计方法的发展。本文着眼于今天首批AML试验的指导原则在多大程度上仍然适用，