Statistical design and analysis of response adaptive clinical trials

随机化的使用在临床试验中是必不可少的，因为它掩盖了治疗的特性，促进了治疗组的相似性，并验证了统计数据的使用。然而，在绝望的医疗情况下，平衡随机化的黄金标准有利于集体伦理（即试验后患者的利益），但阻碍了个人伦理（即试验中患者的最高利益），因此在伦理上变得不可行。反应适应性随机化的使用缓解了这种冲突，其目的是评估和利用积累的信息，在不损害临床研究的有效性和完整性的情况下提高试验的效率和伦理性。试验中的大多数患者都希望在不牺牲集体伦理的情况下接受可能更好的治疗。这是一个非常重要的问题，因为在21世纪，医学研究对个人护理的需求越来越大。

The use of randomization is essential in clinical trials because it masks the treatment identity, promotes the similarity of treatment groups and validates the use of statistics. However in desperate medical situations, the gold standard of balanced randomization favors the collective ethics (i.e., the benefits to the patients after the trial) but hinders the individual ethics (i.e., the paramount interests of the patients in the trial), and hence becomes ethically infeasible. This conflict is alleviated with the use of response adaptive randomization, the goal of which is to evaluate and utilize the accumulating information so as to improve the efficiency and ethics of the trial without undermining the validity and integrity of the clinical research. Most patients in the trial are expected to receive the potentially superior treatment without sacrifice to the collective ethics. This is a very important issue because in the 21st century, there is a greater demand of personal care in medical research.