Which of the following is not usually considered a controlled trial? (As in FDA’

Question

Which of the following is not usually considered a controlled trial? (As in FDA’s definition of an “adequate and well controlled trial”?)

a. Comparison of drug treated group to a similar group not treated with that drug in the medical

literature

b. Comparison of one group taking a high dose to another group taking a low dose of the same

drug

c. Reports of individual patients treated with a new drug

d. Comparison of a drug treated group to another group not treated at all

e. Most phase 3 “pivotal trials” upon which provide efficacy evidence

Explanation / Answer

Correct option is option a .Controlled trial is all about comparison of group results out of which one group is trialled by that drug while other group is treated with standard treatment or placebo.

So we should choose option A here.

Thank you

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