Randomized Controlled Trial

Three hundred children attending an elementary school in Ethiopia without any prior history of malaria were each assigned at random to one of two groups after the investigators sought appropriate parental consent. The children in the first group received a new vaccine for malaria, and the children in the other group received a saline solution. After one year, the incidence of malaria was computed among the children based on whether they had received the vaccine or not. The children receiving the vaccine had a substantially lower incidence of malaria as a group than the children receiving the saline solution, thereby confirming the anticipated efficacy of the vaccine. What type of study is this?

  • A. Randomized Controlled Trial
  • B. Prospective Cohort Study
  • C. Retrospective Cohort Study
  • D. Case-Control Study

The following statement describes which phase of an RCT?

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“Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.”

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  • A.Phase 1
  • B.Phase 2
  • C.Phase 3
  • D.Phase 4

 

In: Nursing

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