Question

In: Biology

How is a clinical trial for a medical device similar to or different from a clinical...

How is a clinical trial for a medical device similar to or different from a clinical trial for a drug?

Solutions

Expert Solution

The study for a clinical trial for a drug is similar to the study for a clinical trial for a medical device in the following ways

  • Both the studies involve a control group.
  • Both the trials can compare to the approved therapies.

The clinical trials for a drug differ from the clinical trials for a medical device in the following ways

Clinical trial for a drug Clinical trial for a medical device
Randomization of samples is common. Often there is no randomization
Involves large population with the use of placebos Small populations and rarely uses placebos
Difficulty in visualization Ability to visualization
Ability to "blind" the samples Difficult to "blind"

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