A Simple Guide to Randomized Controlled Trials.

ABSTRACT

Randomized controlled trials represent the cornerstone for the regulatory approval of drugs and evidence-based medicine and policy. Compared with observational studies random assignment of participants to each study arm guarantees an equal distribution of potential confounders thus achieving impartiality in the evaluation of between group differences and allowing for causal inferences to be drawn. These complex and costly medical experiments are tightly regulated and require substantial planning with great attention to several methodological aspects ranging from allocation concealment and blinding to sample size estimation, statistical analysis, and handling of protocol deviations. This brief guide offers useful insights into the design, conduct, and interpretation of clinical trial findings for beginners.