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Randomized Clinical Trials
A clinical trial is defined as a controlled, prospective assessment of an intervention for a disease or condition in human beings. In general, the purposes of randomized clinical trials, or Phase III trials, are to evaluate the efficacy of a novel treatment relative to an observation/placebo arm, or a standard therapy, or to determine whether an experimental treatment is more effective than a standard therapy having lesser morbidity. According to http://ClinicalTrials.gov, Phase III trials
are expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and [sic] adequate basis for physician labeling.
In essence, the ultimate goal of a Phase III clinical trial ...
- Basis for Making the Decision
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