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06/04/2022
Missing data imputation for a multivariate outcome of mixed variable types
Data collected in clinical trials are often composed of multiple types o...
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06/03/2022
Accurate collection of reasons for treatment discontinuation to better define estimands in clinical trials
Background: Reasons for treatment discontinuation are important not only...
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12/17/2021
Selection bias in the treatment effect for a principal stratum
Estimation of treatment effect for principal strata has been studied for...
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12/06/2021
Using principal stratification in analysis of clinical trials
The ICH E9(R1) addendum (2019) proposed principal stratification (PS) as...
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11/22/2021
Monotonicity assumptions in estimating the treatment effect for a principal stratum
In addition to the treatment effect for all randomized patients, sometim...
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11/17/2021
Return-to-baseline multiple imputation for missing values in clinical trials
Return-to-baseline is an important method to impute missing values or un...
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08/04/2021
Analysis of an Incomplete Binary Outcome Dichotomized From an Underlying Continuous Variable in Clinical Trials
In many clinical trials, outcomes of interest include binary-valued endp...
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02/06/2021
Estimating the treatment effect for adherers using multiple imputation
Randomized controlled trials are considered the gold standard to evaluat...
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12/19/2020
Revisiting ICH E9 (R1) during the COVID-19 pandemic
The current COVID-19 pandemic poses numerous challenges for ongoing clin...
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06/10/2020
Understanding and adjusting the selection bias from a proof-of-concept study to a more confirmatory study
It has long been noticed that the efficacy observed in small early phase...
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06/04/2020
Defining Estimands Using a Mix of Strategies to Handle Intercurrent Events in Clinical Trials
Randomized controlled trials (RCT) are the gold standard for evaluation ...
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05/29/2020
Implementation of Tripartite Estimands Using Adherence Causal Estimators Under the Causal Inference Framework
Intercurrent events (ICEs) and missing values are inevitable in clinical...
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04/12/2019