Adaptive Randomization
Shein-Chung Chow, Mark Chang · 2011
Randomization plays an important role in clinical research. For a given clinical trial, appropriate use of randomization procedure not only ensures that the subjects selected for the clinical trial are a truly representative sample of the target patient population under study, but also provides an unbiased and fair assessment regarding the efficacy and safety of the test treatment under investigation. As pointed out in Chow and Liu (2003), statistical inference of the efficacy and safety of a test treatment under study relies on the probability distribution of the primary study endpoints of the trial, which in turn depends on the randomization model/method employed for the trial. Inadequate randomization model/method may violate the primary distribution assumption and consequently distort statistical inference. As a result, the conclusion drawn based on the clinical data collected from the trial may be biased and/or misleading.