Clinical trials are the gold standard in study design for evaluating the benefits and harms of interventions. The National Institutes of Health defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The drugs, biologics, and devices that we use to treat or prevent diseases, lengthen our lives, or improve how we feel or function are evaluated using clinical trials. Behavioral and educational interventions are evaluated in clinical trials, too. Big elements in the clinical trial toolbox include randomization (possibly with stratification), blinding, the use of control groups, and prospective observation.
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