Statistical methodology for the adaptive design and analysis of clinical trials

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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.