Table 2

Clinical Prediction Guides (CPG) for individualising treatment effects

Type of trial	Type of control	CPG to predict control risk for target event: population	CPG to predict control risk for harm: population
Superiority trial	Placebo or no treatment	CPG developed on patients on placebo or no treatment	Fixed harm: CPG not needed
	Placebo or no treatment	CPG developed on patients on placebo or no treatment	Variable harm: CPG developed on patients on placebo or no treatment*
	Active control (EET)	CPG developed on patients on EET†	Fixed harm: CPG not needed
	Active control (EET)	CPG developed on patients on EET†	Variable harm: CPG developed on patients on EET
Non-inferiority trial	Active control (EET)	CPG developed on patients on EET†	Fixed harm: CPG not needed
Non-inferiority trial	Active control (EET)	CPG developed on patients on EET†	Variable harm: CPG developed on patients on EET

*If a validated CPG developed on treated patients is used (see worked example on warfarin), the individualised risk for the harm off treatment can be obtained by dividing the risk on treatment by the group-level relative risk for the harm with the treatment compared with placebo or no treatment.
†If a validated CPG developed on patients on placebo or no treatment is used, the individualised risk for the target event while on EET can be obtained by multiplying the risk off treatment by the group-level relative risk for the target event on EET compared with placebo or no treatment.
EET, established effective therapy.