Group-Sequential Designs in Clinical Trials

If the main interest of a clinical trial is to determine whether a new treatment results in a better outcome than the existing treatment, investigators often would like to obtain the result as soon as possible. One of the reasons for that is that if one treatment is clearly superior to the other, it is unethical to continue the inferior treatment. Standard methods, which fix the length of a study and conduct only one significance test at the end of the study to compare treatments, are inefficient in terms of use of time and cost. Therefore, one question that needs to be answered is whether one can predict with certainty the outcome of the trial before the end of the study based on interim data. ...

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