Knowledge check 2
Which of the following statements concerning the phases of drug development are true?
Select true or false for each of the statements.
Which of the following statements concerning the phases of drug development are true?
Select true or false for each of the statements.
A. False. Phase I studies have traditionally been conducted in volunteers, but more and more new drugs are now tested in patients from the outset.
B. False. Phase II studies are usually part of the learning stage of drug development.
C. True. Modern drug development increasingly uses biomarkers as surrogates to assess the pharmacodynamic activity of new drugs rather than hard clinical endpoints.
D. False. Phase III studies are indeed conducted in patients but they are usually large-scale involving hundreds possibly thousands of subjects. The principal objective is usually to confirm the magnitude of the treatment benefit of the drug at doses shown to be associated with benefit in phase II studies. Phase III studies also provide the principal source for the safety data on a new drug.
E. False. Phase IV studies may not be optional if a regulatory authority requests them as a condition of the license.
