A "Phase III prospective externally controlled trial" refers to a clinical trial in the final stage of drug development (Phase III) where the experimental treatment is compared to a control group drawn from an external source, meaning the control patients are not part of the same study but are sourced from another data set, like concurrent trials, allowing researchers to assess the efficacy of the new treatment against standard care without directly enrolling a control group within the trial itself; this is typically done when it is difficult or unethical to randomize patients to a control arm in a traditional Phase III trial.
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