Introduction to Epidemiology 6th Edition by Ray M Merrill

Exercise 6

Which of the answer sets below best matches the definitions in the left column with the phases of trials listed in the right column?

___ Studies involving animals or cell cultures	A. Preclinical
___ Conducted to determine the safety of a treatment in humans. Patients go through intense monitoring	B. Phase I
___ Large studies (may or may not be a randomized trial) conducted after the therapy has been approved by the FDA to assess the rate of serious side effects and explore further therapeutic uses	C. Phase II
	D. Phase III
	E. Phase IV
___ Relatively large randomized blinded trials used to evaluate the efficacy of an intervention
___ Investigator explores test tolerability, safe dosage, side effects, and how the body copes with the drug

Step 1 of 4

It has been considered that selection of intervention entirely depends on the research objectives by treating or preventing disease. In clinical trials, it aimed at evaluating the efficacy of a specific treatment in which the invigilator solely proved that the therapy is safe and active against the disease. It also provides evidence that the therapy is potentially better than another and is likely to be implementing in the field survey.