Randomized Clinical Trials

A systematic study of medical interventions in human subjects (including patients and other volunteers) in which study subjects are randomly assigned to treatment and control groups. Used to discover or verify the effects of and/or identify any adverse reactions to investigational products, and/or to study the absorption, distribution, metabolism and excretion of the products with the objective of ascertaining their efficacy and safety. Studies in which neither the investigator nor the study subjects know to which group, treatment or control, they have been assigned until the conclusion of the study are referred to as ‘double-blind randomized clinical trials’ and are considered the gold standard for drug and vaccine efficacy research.