Knowledge check 3
Which of the following statements concerning the management of risk during drug development are true?
Select true or false for each of the statements.
Feedback 
A. False. Drug therapy is always a balance of benefit and risk. Even the most serious adverse effects can be acceptable depending on the benefits associated with the drug and the patient population for which it is used.
B. False. Even large Phase III trials involving over a thousand patients may fail to reveal serious drug-related adverse effects, especially if they are uncommon and occur to some extent in the control group as well.
C. False. Although a new mechanism of action, target or clinical indication are of scientific interest the more important considerations are whether (i) it improves the benefit/risk balance compared to standard therapy, and (ii) whether it is a cost-effective use of limited healthcare resources compared to the older (usually cheaper) alternatives.
D. False. Around three quarters of the drugs that enter Phase I fail to reach the market.
E. True. Effective biomarkers that are good surrogates for the long term clinical benefits of new drugs allow accurate prediction of likely clinical effectiveness to be based on short-term studies in relatively small numbers of patients.
