Categories of Clinical Trials

Question 1

Phase 0

Answer 1

exploratory, first in-human trials; speed up development of promising drugs; single does given to 10-15 healthy patients

Question 2

Phase I

Answer 2

evaluates the safety, tolerability, pharmacokinetic properties, and pharmacological effects of the drug; 20-100 healthy patients

Question 3

Phase II

Answer 3

assesses the effectiveness of the drug; side effects and safety; few hundred diseased patients

Question 4

Phase III

Answer 4

larger; establishes the efficacy of the drug; several thousand diseased patients; compare drug to similar drugs on the market