A clinical trial powered to show the efficacy of a drug in a specific disease population, with the goal of using these data as part of a marketing application, is usually considered a _____ study

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09-09-2022
Social Studies

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A clinical trial powered to show the efficacy of a drug in a specific disease population, with the goal of using these data as part of a marketing application, is usually considered a _____ study

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topeadeniran2 topeadeniran2 · Answer 1 · 2022-09-13T17:32:04+02:00

A clinical trial powered to show the efficacy of a drug in a specific disease population, with the goal of using these data as part of a marketing application, is usually considered a Phase 4 clinical trial study.

What does a clinical trial's Phase 4 entail?

This is a kind of clinical research that examines long-term side effects brought on by a novel treatment after it has received regulatory approval and is available on the market.

These studies may also examine the effectiveness of a novel medication over an extended period of time while searching for side effects that were not detected in previous studies.

In this case, the clinical trial powered to show the efficacy of a drug in a specific disease population, with the goal of using these data as part of a marketing application, is usually considered a Phase 4 clinical trial study.

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