The Clinical Utility Index, a Method for Balancing Efficacy and Safety ...

Low High Value
Not clinically meaningful -0.3 0 0.00
Efficacy
Examples from our case study: meaningful response ranges and their
(maximal change in SES) Moderately effective -0.6 -0.3 0.60
preference values, as assessed Excellent by (super the drug) project team -1.2 -0.6 1.00
Hypotension
(maximal change in SBP, mm Hg)
Endpoint
Drowsiness/Somnolence
(% incidence)
Efficacy
(maximal change in SES)
Worse than competitor X -30 -15 0.20
Effectively the same -15 -5 0.70
Clearly better -5 0 1.00
Range name
Range values
Low High Value
Severe
Not clinically
impact
meaningful
0.52
-0.3
0.78
0
0.20
0.00
Moderate
Moderately
impact
effective
0.26
-0.6
0.52
-0.3
0.60
0.60
Mild
Excellent
impact
(super drug)
0.00
-1.2
0.26
-0.6
1.00
1.00
Duration
Hypotension
of effect (h)
(maximal change in SBP, mm Hg)
Worse than competitor X 0.00 -30 2.00 -15 0.00 0.20
Effectively Effectively the the same
Clearly same 2.00 -15 5.00 -5 0.50
0.70
Clearly
better
better
5.00
-5
12.00
0
1.00
1.00
Dyskinesia (% incidence)
Drowsiness/Somnolence
(% incidence)
Worse than competitor X 0.35 0.40 0.15
Effectively
Severe impact
the same 0.15
0.52
0.35
0.78
0.70
0.20
Clearly
Moderate
better
impact
0.00
0.26
0.15
0.52
1.00
0.60
Mild impact 0.00 0.26 1.00
Duration of effect (h)
Worse than competitor 0.00 2.00 0.00
Effectively the same 2.00 5.00 0.50
Clearly better 5.00 12.00 1.00
Dyskinesia (% incidence)
Worse than competitor X 0.35 0.40 0.15
Effectively the same 0.15 0.35 0.70
Clearly better 0.00 0.15 1.00
slide 18