ABSTRACT
This chapter discusses the importance of the randomization process and its reporting in a clinical trial setting. The discussion begins by deconstructing 17 clinical trials that were previously labeled, by Elangovan et al., as either “low risk,” “high risk,” or “unclear risk” for bias. The argument that further evaluation of these 17 clinical trials can reveal a higher risk of bias than previously shown is made. Within the chapter, the reader systematically goes through many of the trials presented by Elangovan et al. to analyze where and how bias can arise. The aim is to illustrate the detrimental effects faulty randomization and a poor explanation of the process can have on the reported results of a clinical study and how this can, in turn, increase risk of bias. This chapter explains why none of the 17 trials analyzed are at a low risk for bias, and all 17 should be considered “high risk.” Ultimately, the purpose is to help researchers understand the hidden dangers of using flawed methodologies and inadequate reporting, so that they can ensure the integrity of their clinical trial.
