The Hardest Problem There Is
Assessing and Communicating Heterogeneity of Treatment Effects (HTE)
for Patient Subpopulations: Challenges and Opportunities
Subgroup Identification
The Hardest Problem There Is
Stephen J. Ruberg, PhD President
Analytix Thinking, LLC AnalytixThinking@
3/6/2018
ANALYTIX THINKING, LLC (C) 2018
1
Outline
Clinical Trials Observational Data What We Can Do Now
3/6/2018
ANALYTIX THINKING, LLC (C) 2018
2
Clinical Trials
Treatment versus Control
Population of Interest
Treatment Effect = 10%
X47 < 42
Treatment Effect = 30%
Subgroup of Interest
(50% of Population)
X11 < 5
3/6/2018
ANALYTIX THINKING, LLC (C) 2018
3
X47 < 42
Clinical Trials
Treatment versus Control
Population of Interest
Effect = 10%
Complexity
Size of Subpop'n 10%, 25%, 50%
Effect = 30%
Subgroup of Interest
(50% of Population)
X11 < 5
3/6/2018
ANALYTIX THINKING, LLC (C) 2018
4
X47 < 42
Clinical Trials
Treatment versus Control
Population of Interest
Effect = 10%
Complexity
Differential Effect 0%, 5%, 15%, 25%, 50%
Effect = 30%
Subgroup of Interest
(50% of Population)
X11 < 5
3/6/2018
ANALYTIX THINKING, LLC (C) 2018
5
X47 < 42
Clinical Trials
Treatment versus Control
Population of Interest
Effect = 10%
Effect = 30%
Subgroup of Interest
(50% of Population)
Complexity
Number of biomarkers in the dataset X1, X2, X3 ... X110
10, 25, 75, 250, 500
X11 < 5
3/6/2018
ANALYTIX THINKING, LLC (C) 2018
6
X47 < 42
Clinical Trials
Treatment versus Control
Population of Interest
Effect = 10%
Complexity
Number of biomarkers defining subpop'n
1, 2
Effect = 30%
Subgroup of Interest
(50% of Population)
X11 < 5
3/6/2018
ANALYTIX THINKING, LLC (C) 2018
7
X47 < 42
Clinical Trials
Treatment versus Control
Population of Interest
Effect = 10% Effect = 20%
Complexity
Nature of biomarkers effect
1, 2
Effect = 30%
Effect = 40%
Effect = 50%
X11 < 5
3/6/2018
ANALYTIX THINKING, LLC (C) 2018
8
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