Understanding of Randomization and its reporting in Randomized Controlled Trials

Abstract

Under the present era of evidence-based healthcare in general and evidence-based medicine in particular, while searching for a new and/or more efficacious/economic intervention/drug, an optimal solution is obtained from a well-planned randomized controlled trial (RCT). For this, to avoid unexpected biases, random allocation (i.e., randomization) of considered patients in different treatment/intervention arms is mandatory. In other words, an experimental study without involving random allocation of patients between treatment arms is never an RCT. Depending on the considered research question/hypothesis/objective of the RCT, the structure of the study population, and the study design, one of the various approaches of randomization may be used. The aim of this write-up is to address a few important issues related to involved randomization under RCT.