Clinical trials

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Questions

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USMLE® Step 2 style questions USMLE

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A study is conducted to determine the long term effects of a novel vaccine against the SARS-CoV-2 virus, which causes coronavirus disease 19 (COVID-19). To do so, researchers followed individuals who had received the vaccine for one year. They discovered the vaccine is associated with an increased incidence of fever of unknown origin and new-onset heart failure with reduced ejection fraction in 25 patients out of the 1 million total patients who were followed. Based on these results, an additional warning about these adverse events is added to the investigator brochure for the vaccine. Which of the following clinical phases does this study most likely belong to?  

Summary

Clinical trials are research studies that test how well new medical treatments work in people, and they are used to determine whether a new treatment is safe and effective. In most cases, people participating in clinical trials do not receive any direct benefit from it.

Clinical trials usually involve two types of participants: the experimental group, the control group, and the placebo group. The experimental group receives the new treatment; the control group receives a standard treatment or placebo (a medicine or other preparation with no therapeutic effect).

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