Roadmap for Causal Inference in Safety Analysis
Jordan C. Brooks, Alan S. Go, Daniel E. Singer, and Mark J. van der LaanSafety analysis involves assessing the causal effect of a treatment or exposure regimen on one or more outcomes of interest based on observing a sample of subjects over time. The observed data might constitute an observational s...
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| Published in: | Quantitative Evaluation of Safety in Drug Development pp. 190 - 211 |
|---|---|
| Format: | Book Chapter |
| Language: | English |
| Published: |
United Kingdom
Chapman and Hall/CRC
2015
CRC Press LLC |
| Subjects: | |
| ISBN: | 9781466555457, 1466555459 |
| Online Access: | Get full text |
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| Abstract | Jordan C. Brooks, Alan S. Go, Daniel E. Singer, and Mark J. van der LaanSafety analysis involves assessing the causal effect of a treatment or exposure
regimen on one or more outcomes of interest based on observing a sample
of subjects over time. The observed data might constitute an observational
study or a randomized controlled trial or even a collection of observational
or randomized studies. Since randomized trials are typically not poweredCONTENTS10.1 Introduction and Motivation ... 173
10.2 Roadmap for Safety Analysis ... 17710.2.1 Observed Data Structure ... 177
10.2.2 Structural Causal Model ... 177
10.2.3 Causal Quantities ... 178
10.2.4 Identiability Result ... 179
10.2.5 Statistical Model, Statistical Target Parameter,and Estimation Problem ... 179
10.2.6 Inuence Curve for Inference ... 180
10.2.7 Multiple Testing Based on Joint Distribution ... 180
10.2.8 Sensitivity Analysis ... 18110.3 TMLE ... 181
10.3.1 Super Learning ... 18210.4 TMLE of Intervention-Specic Mean ... 183
10.5 Safety Analysis of Warfarin: The Causal Effect on NonstrokeDeath in Atrial Fibrillation ... 185
10.5.1 ATRIA-1 Cohort Data ... 186
10.5.2 Causal Effect of Warfarin Parameter ... 187
10.5.3 TMLE Implementation ... 187
10.5.4 Results ... 18710.6 Concluding Remark ... 189
References ... 189for safety outcomes, it is not uncommon that one combines various randomized studies, possibly augmented with observational studies, in order to
evaluate safety signals in the data. |
|---|---|
| AbstractList | Jordan C. Brooks, Alan S. Go, Daniel E. Singer, and Mark J. van der LaanSafety analysis involves assessing the causal effect of a treatment or exposure
regimen on one or more outcomes of interest based on observing a sample
of subjects over time. The observed data might constitute an observational
study or a randomized controlled trial or even a collection of observational
or randomized studies. Since randomized trials are typically not poweredCONTENTS10.1 Introduction and Motivation ... 173
10.2 Roadmap for Safety Analysis ... 17710.2.1 Observed Data Structure ... 177
10.2.2 Structural Causal Model ... 177
10.2.3 Causal Quantities ... 178
10.2.4 Identiability Result ... 179
10.2.5 Statistical Model, Statistical Target Parameter,and Estimation Problem ... 179
10.2.6 Inuence Curve for Inference ... 180
10.2.7 Multiple Testing Based on Joint Distribution ... 180
10.2.8 Sensitivity Analysis ... 18110.3 TMLE ... 181
10.3.1 Super Learning ... 18210.4 TMLE of Intervention-Specic Mean ... 183
10.5 Safety Analysis of Warfarin: The Causal Effect on NonstrokeDeath in Atrial Fibrillation ... 185
10.5.1 ATRIA-1 Cohort Data ... 186
10.5.2 Causal Effect of Warfarin Parameter ... 187
10.5.3 TMLE Implementation ... 187
10.5.4 Results ... 18710.6 Concluding Remark ... 189
References ... 189for safety outcomes, it is not uncommon that one combines various randomized studies, possibly augmented with observational studies, in order to
evaluate safety signals in the data. |
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| Keywords | Causal Quantities True Q0 Self-controlled Case Series Van Der Laan Condence Intervals Target Parameter Structural Causal Model Clever Covariate Safety Analysis Multiple Testing Procedure Intervention Nodes HLGT Exclusion Restriction Assumption DMC Member Data Monitoring Committee Linear Discriminant Analysis Observed Data Structure Efcient Estimators Standardize MedDRA Query Asymptotic Linearity Time Dependent Covariates Non-inferiority Trials Cox Proportional Hazards Regression Model Super Learner |
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| Snippet | Jordan C. Brooks, Alan S. Go, Daniel E. Singer, and Mark J. van der LaanSafety analysis involves assessing the causal effect of a treatment or exposure
regimen... |
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| SubjectTerms | Clinical trials Pharmaceutical technology Probability & statistics |
| Title | Roadmap for Causal Inference in Safety Analysis |
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