Canadian Health Information Management Association Practice Exam

Which of the following represents the 'gold standard' for clinical trials?

1. a cohort study.

2. b double blind trial.

3. c randomized control trial.

4. d triple blind trial.

The correct answer is: c randomized control trial.

The 'gold standard' for clinical trials is the randomized control trial (RCT). This study design is highly regarded because it minimizes bias and allows for a clearer interpretation of the cause-and-effect relationship between an intervention and its outcomes. In an RCT, participants are randomly assigned to either the intervention group or the control group, which helps ensure that any differences observed between the two groups are due to the intervention itself rather than other confounding factors. This randomization reduces selection bias, and as a result, the findings are often considered more reliable and valid. While double-blind and triple-blind trials are important as they further enhance the integrity of the trial by preventing potential biases from both the participants and researchers, it is the RCT format itself that provides the fundamental structure needed to establish these relationships between treatments and outcomes in a way that other study designs, such as cohort studies, cannot reliably offer. Thus, the randomized control trial is recognized as the most rigorous standard in clinical research.