Clinical Trials
Clinical trials are systematic investigations on human subjects testing the safety and efficacy of novel medical interventions, including drug, surgical, or behavioral treatments. Conventionally clinical trials are divided into four types or phases. In a phase I clinical trial, typically involving tens of subjects, a novel procedure is tested for the first time in human beings and data is collected on safety. In a phase II trial, which may involve hundreds of patients, evidence is sought that a novel intervention has a therapeutic effect on the disease of interest. In a phase III clinical trial, often involving thousands of patients, the novel intervention is compared to a standard intervention or placebo. In a phase IV trial, called a post-marketing study, information is collected on the long-term safety and efficacy of the intervention from patients receiving the intervention in clinical practice and measured against a control treatment. The rigorous evaluation of novel medical interventions in clinical trials is a foundation of evidence-based medicine.
Historical Development
The randomized clinical trial is one of the most important advances in medicine in the twentieth century. Prior to its development, treatments were adopted on the basis of the publication of a series of cases in which their use had proved helpful.
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