ABSTRACT
One must be skeptical with those clinical trials (CTs) that claim to be randomized but do not describe the randomization process (PR). We are accustomed to reading that the randomized clinical trial (RCT) is “the best evidence for…” However, RCT is not synonymous to randomization-based clinical trial (R-bCT). It should be the best evidence for judging merits of an intervention, as long as research workers used a proper randomization process (PRP): adequate sequence generation and allocation concealment of generation (randomness). R-bCT helps to solve the clinical uncertainty (equipoise), facilitates the comparability of the groups, and leads to a clinical practice based on the best evidence. PRP should be seen as the light ray to increase the internal validity of a CT. Absence of PRP means Chaos! (synonymous confusion bias secondary to allocation bias). In this chapter, the following are discussed: randomization, its purpose, web tools to perform an PRP, the close relationship between randomization and sample size, and, finally, examples of how randomization should be described. This chapter does not describe randomization techniques and their less statistical properties. No to RCTs without a proper randomization process as a way to reduce waste biomedical research.
