Statistical Modelling for Adaptive Design of Clinical Trials: Optimality and Efficiency

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Response adaptive design (RAD) has ethical advantages over traditional methods for clinical trials, but it also introduces dependency into data. Most statistical literature on RAD focused on statistical methodologies for mean response models without considering population heterogeneity. Ignoring such heterogeneity could introduce bias into conclusions. In addition, patients exposed to different environmental factors may respond to treatments very differently. All these are the main reasons why the efficacious treatments recommended by randomized clinical trials do not always work in day-to-day health care.