In Phase III of the Clinical Trial Process, Doctors compare the treatment with the standard of care for that disease. They do so by gathering data from how many patients?

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Understanding the question: In Phase III of the Clinical Trial Process, Doctors compare the treatment with the standard of care for that disease by gathering data from how many patients?
Option a) 200-300: While Phase III trials involve large patient groups, 200-300 is on the lower end and may not be representative enough for robust statistical comparisons across diverse populations. This range is more typical of Phase II or smaller-scale studies, not the definitive Phase III comparison against standard of care.
Option b) 300+: This aligns with the common characterization of Phase III trials as large-scale studies designed to assess efficacy and safety against the current standard treatment. Enrolling 300 or more participants provides sufficient power to detect clinically meaningful differences and to generalize results to the broader patient population.
Option c) 50-100: This range is characteristic of early-phase studies (Phase I/II) focusing on safety, dosing, and initial efficacy signals. It is far too small for the confirmatory, comparative aims of Phase III.
Option d) 100-200: While larger than early-phase trials, this range is still typically considered insufficient for the comprehensive, diverse populations and statistical power that Phase III trials aim for. It would be more characteristic of mid-sized Phase II/III exploratory efforts, not the standard Phase III design.
In summary, the core purpose of Phase III is to compare a new therapy with the established standard of care in a large, adequately powered population to confirm efficacy and monitor safety across diverse subgroups. Therefore, a sample size of 300+ participants best fits this phase’s typical design.

In Phase III of the Clinical Trial Process, Doctors compare the treatment with the standard of care for that disease. They do so by gathering data from how many patients?

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