Standard and reference‐based conditional mean imputation
M Wolbers, A Noci, P Delmar… - Pharmaceutical …, 2022 - Wiley Online Library
Clinical trials with longitudinal outcomes typically include missing data due to missed
assessments or structural missingness of outcomes after intercurrent events handled with a …
assessments or structural missingness of outcomes after intercurrent events handled with a …
[HTML][HTML] Estimands in CNS trials–A review of strategies for addressing intercurrent events
L Mészáros, F Lasch, B Delafont, L Guizzaro - Contemporary Clinical Trials …, 2024 - Elsevier
Background The estimands framework represents a significant innovation for the design,
conduct, analysis, and interpretation of clinical trials. An aim of the framework is to increase …
conduct, analysis, and interpretation of clinical trials. An aim of the framework is to increase …
A Causal Mediation Approach to Account for Interaction of Treatment and Intercurrent Events: Using Hypothetical Strategy
K Wu, X Zhang, M Zheng, J Zhang… - Statistics in …, 2024 - Wiley Online Library
Hypothetical strategy is a common strategy for handling intercurrent events (IEs). No current
guideline or study considers treatment–IE interaction to target the estimand in any one IE …
guideline or study considers treatment–IE interaction to target the estimand in any one IE …
[PDF][PDF] rbmi: AR package for standard and reference-based multiple imputation methods
C Gower-Page, A Noci, M Wolbers - Journal of Open Source Software, 2022 - joss.theoj.org
Many randomized controlled clinical trials compare a continuous outcome variable that is
assessed longitudinally at scheduled follow-up visits between subjects assigned to a …
assessed longitudinally at scheduled follow-up visits between subjects assigned to a …
Estimation of treatment policy estimands for continuous outcomes using off treatment sequential multiple imputation
The estimands framework outlined in ICH E9 (R1) describes the components needed to
precisely define the effects to be estimated in clinical trials, which includes how post …
precisely define the effects to be estimated in clinical trials, which includes how post …
Handling Partially Observed Trial Data After Treatment Withdrawal: Introducing Retrieved Dropout Reference‐Base Centred Multiple Imputation
S Cro, JH Roger, JR Carpenter - Pharmaceutical statistics, 2024 - Wiley Online Library
ABSTRACT The ICH E9 (R1) Addendum (International Council for Harmonization 2019)
suggests treatment‐policy as one of several strategies for addressing intercurrent events …
suggests treatment‐policy as one of several strategies for addressing intercurrent events …
Estimation methods for estimands using the treatment policy strategy; a simulation study based on the PIONEER 1 Trial
J Bell, T Drury, T Mütze, CB Pipper, L Guizzaro… - arXiv preprint arXiv …, 2024 - arxiv.org
Estimands using the treatment policy strategy for addressing intercurrent events are
common in Phase III clinical trials. One estimation approach for this strategy is retrieved …
common in Phase III clinical trials. One estimation approach for this strategy is retrieved …
The Estimand Framework and Causal Inference: Complementary not Competing Paradigms
T Drury, JW Bartlett, D Wright, ON Keene - arXiv preprint arXiv:2412.12380, 2024 - arxiv.org
The creation of the ICH E9 (R1) estimands framework has led to more precise specification
of the treatment effects of interest in the design and statistical analysis of clinical trials …
of the treatment effects of interest in the design and statistical analysis of clinical trials …
Sequential linear regression for conditional mean imputation of longitudinal continuous outcomes under reference-based assumptions
S Yiu - Computational Statistics, 2024 - Springer
In clinical trials of longitudinal continuous outcomes, reference based imputation (RBI) has
commonly been applied to handle missing outcome data in settings where the estimand …
commonly been applied to handle missing outcome data in settings where the estimand …