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Statistical Methods in Medical Research
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Adaptive designs for binary treatment responses in phase III clinical trials: controversies and progress

Atanu Biswas

Applied Statistics Unit, Indian Statistical Institute, Kolkata, India, atanu{at}isical.ac.in

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.

Statistical Methods in Medical Research, Vol. 10, No. 5, 353-364 (2001)
DOI: 10.1177/096228020101000504
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