TABLE 1.

A comparison of targeted and untargeted approaches to risk assessment.

Aspect of risk assessment	Untargeted	Targeted
Underlying philosophy	Empiricism	Critical rationalism
Objective	Proof of safety	A tool to support decision-making
Hypothesis tested	No difference from comparator	No unacceptable risk
Number of endpoints	As many as possible	As few as necessary
Decision-making criteria	Sought in the data	Predetermined by policy
Output	Complete understanding	Acceptability of risk
Incorporating scientific advances	Precautionary neophilia	If it ain’t broke, don’t fix it
Resulting decisions	Obscure, arbitrary, disputed	Clear, predictable, accepted