Statistical methodology for the adaptive design and analysis of clinical trials

随机临床试验是一种有效的工具，可以得出新的医疗干预措施的有效结论，从而使试验之外的未来患者受益（集体伦理）。平衡随机化被认为是临床试验的金标准。然而，这种随机化引起了伦理问题，因为一半的参与者被分配到次等干预，牺牲了个人伦理。根据个人护理原则，考虑到临床试验中患者的福祉（个体伦理），在临床试验中很难或不可能实施随机化。为了缓解集体伦理与个人伦理之间的紧张关系，提出了响应适应性设计。

A randomized clinical trial is an efficient tool to draw a valid conclusion on a new medical intervention to benefit future patients outside the trial (collective ethics). Balanced randomization is considered as the gold standard in clinical trials. However, this randomization raises ethical concerns because half of the participants are allocated to the inferior intervention and individual ethics is sacrificed. According to the personal care principle, it is difficult or impossible to implement randomization in a clinical trial considering the well-being of patients in the trial (individual ethics). Response adaptive designs are proposed to alleviate the tension between the collective and individual ethics.