Adaptive designs for binary treatment responses in phase III clinical trials: controversies and progress.
In phase III clinical trials the problem is to compare two treatments or therapies for their effects. The randomized 50:50 allocation to the two competing treatments is popular in most of the cases. In contrast there is a class of adaptive designs available in literature for this purpose. The object is to treat a larger number of patients by the eventual better treatment. A few such adaptive designs were conducted out in practical applications and consequently a lot of controversy arose. In spite of that there is steady theoretical progress in this area over the past three decades. The present paper reviews some of the real-life adaptive clinical trials and discusses some logistics of such trials.
Biswas
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Applied Statistics Unit, Indian Statistical Institute, 203 B.T. Road, Kolkata 700 035, India. atanu@isical.ac.in
D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D006801:Humans; D011379:Prognosis; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012107:Research Design; D016896:Treatment Outcome