Clinical Trials

■■❚❙❘Chapter 7RandomizationDuolao Wang and Ameet BakhaiRandomization is the unpredictable allocation of a patient toa particular treatment strategy in a clinical trial. When a largenumber of patients is involved, simple randomization willbalance the groups in a trial for patient characteristics andother factors that might bias outcomes (systematic error orconfounding). The remaining differences in efficacy or safetyoutcomes between the groups can then be assumed to be dueto the effects of the different treatment strategies or randomerror. Randomization is therefore the cornerstone of a wellconductedclinical trial. In this chapter, we describe andexplain some commonly used randomization methodsand their implementation.65