Certified Clinical Research Associate (CCRA) Practice Exam

Randomization plays a crucial role in clinical trial design primarily by introducing equity among study groups. This method ensures that participants are assigned to treatment groups in a way that eliminates bias in the selection process. By randomizing participants, researchers can ensure that the groups are comparable at the start of the trial. This comparability helps in isolating the effect of the intervention from other variables that could influence the outcomes, such as participant characteristics or confounding factors. This equitable distribution of participants helps in maintaining the internal validity of the study, allowing for more reliable conclusions about the efficacy and safety of the treatments being evaluated. Randomization thus protects against selection bias, ensuring that the effects measured can be attributed to the treatment rather than pre-existing differences between groups. In contrast, assigning treatments on a volunteer basis could lead to significant self-selection bias, as volunteers might differ in important ways from non-volunteers. Researcher control may enhance study conditions but does not fundamentally address the need for equitable group assignment. Simplifying the trial structure is beneficial but not a primary reason for implementing randomization.