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Articles

On analysis of longitudinal clinical trials with missing data using reference-based imputation

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Pages 924-936 | Received 06 Feb 2015, Accepted 04 Sep 2015, Published online: 29 Jan 2016

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Alberto García-Hernandez, Teresa Pérez, María del Carmen Pardo & Dimitris Rizopoulos. (2023) A Flexible Analytical Framework for Reference-Based Imputation, Delta Adjustment and Tipping-Point Stress-Testing. Statistics in Biopharmaceutical Research 15:4, pages 781-793.
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Man Jin & Yixin Fang. (2023) Methods for Informative Censoring in Time-to-Event Data Analysis. Statistics in Biopharmaceutical Research 0:0, pages 1-8.
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Jonathan W. Bartlett. (2023) Reference-Based Multiple Imputation—What is the Right Variance and How to Estimate It. Statistics in Biopharmaceutical Research 15:1, pages 178-186.
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G. Frank Liu, Jiajun Liu, Fang Chen, Roee Gutman & Kaifeng Lu. (2022) Bayesian Approaches for Handling Hypothetical Estimands in Longitudinal Clinical Trials With Gaussian Outcomes. Statistics in Biopharmaceutical Research 14:4, pages 626-635.
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Man Jin & Yixin Fang. (2022) On Reference-based Imputation for Analysis of Incomplete Repeated Binary Endpoints. Journal of Biopharmaceutical Statistics 32:5, pages 692-704.
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Rolando Uranga, Geert Molenberghs & Sira Allende. (2022) A multiple regression imputation method with application to sensitivity analysis under intermittent missingness. Communications in Statistics - Theory and Methods 51:15, pages 5146-5161.
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Yilong Zhang, Zachary Zimmer, Lei Xu, Raymond L. H. Lam, Susan Huyck & Gregory Golm. (2022) Missing Data Imputation With Baseline Information in Longitudinal Clinical Trials. Statistics in Biopharmaceutical Research 14:2, pages 242-248.
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Kaifeng Lu. (2021) An Alternative Implementation of Reference-Based Controlled Imputation Procedures. Statistics in Biopharmaceutical Research 13:4, pages 483-491.
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Ian White, Royes Joseph & Nicky Best. (2020) A causal modelling framework for reference-based imputation and tipping point analysis in clinical trials with quantitative outcome. Journal of Biopharmaceutical Statistics 30:2, pages 334-350.
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G. Frank Liu, Fang Liu & Devan V. Mehrotra. (2020) Model Averaging Using Likelihoods That Reflect Poor Outcomes for Clinical Trial Dropouts. Statistics in Biopharmaceutical Research 12:1, pages 79-89.
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Melanie L Bell, Lysbeth Floden, Brooke A Rabe, Stacie Hudgens, Haryana M Dhillon, Victoria J Bray & Janette L Vardy. (2019) Analytical approaches and estimands to take account of missing patient-reported data in longitudinal studies. Patient Related Outcome Measures 10, pages 129-140.
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Fei Gao, Guanghan Liu, Donglin Zeng, Guoqing Diao, Joseph F. Heyse & Joseph G. Ibrahim. (2017) On inference of control-based imputation for analysis of repeated binary outcomes with missing data. Journal of Biopharmaceutical Statistics 27:3, pages 358-372.
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G. Frank Liu & Lei Pang. (2017) Control-Based Imputation and Delta-Adjustment Stress Test for Missing Data Analysis in Longitudinal Clinical Trials. Statistics in Biopharmaceutical Research 9:2, pages 186-194.
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Man Jin. (2024) Imputation methods for informative censoring in survival analysis with time dependent covariates. Contemporary Clinical Trials 136, pages 107401.
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Alberto García‐Hernandez, Teresa Pérez, María del Carmen Pardo & Dimitris Rizopoulos. (2023) An illness–death multistate model to implement delta adjustment and reference‐based imputation with time‐to‐event endpoints. Pharmaceutical Statistics.
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Shu Yang, Yilong Zhang, Guanghan Frank Liu & Qian Guan. (2021) SMIM: A unified framework of survival sensitivity analysis using multiple imputation and martingale. Biometrics 79:1, pages 230-240.
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Siyi Liu, Shu Yang, Yilong Zhang & Guanghan (Frank) Liu. (2022) Sensitivity analyses in longitudinal clinical trials via distributional imputation. Statistical Methods in Medical Research 32:1, pages 181-194.
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Marcel Wolbers, Alessandro Noci, Paul Delmar, Craig Gower‐Page, Sean Yiu & Jonathan W. Bartlett. (2022) Standard and reference‐based conditional mean imputation. Pharmaceutical Statistics 21:6, pages 1246-1257.
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Man Jin. (2022) A hybrid return to baseline imputation method to incorporate MAR and MNAR dropout missingness. Contemporary Clinical Trials 120, pages 106859.
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Marian Mitroiu, Steven Teerenstra, Katrien Oude Rengerink, Frank Pétavy & Kit C. B. Roes. (2022) Estimation of treatment effects in short‐term depression studies. An evaluation based on the ICH E9 ( R1 ) estimands framework . Pharmaceutical Statistics 21:5, pages 1037-1057.
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Yixin Fang & Man Jin. (2022) Sequential modeling for a class of reference‐based imputation methods in clinical trials with quantitative or binary outcomes. Statistics in Medicine 41:8, pages 1525-1540.
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G. Frank Liu & Fang Chen. 2022. Bayesian Inference and Computation in Reliability and Survival Analysis. Bayesian Inference and Computation in Reliability and Survival Analysis 239 259 .
Torfinn S. Madssen, Guro F. Giskeødegård, Age K. Smilde & Johan A. Westerhuis. (2021) Repeated measures ASCA+ for analysis of longitudinal intervention studies with multivariate outcome data. PLOS Computational Biology 17:11, pages e1009585.
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Andrew Atkinson, Suzie Cro, James R. Carpenter & Michael G. Kenward. (2021) Information anchored reference‐based sensitivity analysis for truncated normal data with application to survival analysis. Statistica Neerlandica 75:4, pages 500-523.
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Man Jin, Ran Liu & Weining Robieson. (2021) Modified reference based imputation and tipping point analysis in the presence of missing data due to COVID-19. Contemporary Clinical Trials 110, pages 106575.
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Yixin Fang & Man Jin. (2021) Sample Size Calculation When Planning Clinical Trials with Intercurrent Events. Therapeutic Innovation & Regulatory Science 55:4, pages 779-785.
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M. Mitroiu, K. Oude Rengerink, S. Teerenstra, F. Pétavy & K. C. B. Roes. (2020) A narrative review of estimands in drug development and regulatory evaluation: old wine in new barrels?. Trials 21:1.
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Man Jin & Guanghan Liu. (2020) Estimand framework: Delineating what to be estimated with clinical questions of interest in clinical trials. Contemporary Clinical Trials 96, pages 106093.
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Man Jin, Dai Feng, Guanghan Liu & Shuyan Wan. (2019) Two-level approaches to missing data in longitudinal trials with daily patient-reported outcomes. Statistical Methods in Medical Research 29:7, pages 1935-1949.
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Yilong Zhang, Gregory Golm & Guanghan Liu. (2020) A Likelihood-Based Approach for the Analysis of Longitudinal Clinical Trials with Return-to-Baseline Imputation. Statistics in Biosciences 12:1, pages 23-36.
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Guanghan Liu, Man Jin & Lei Pang. (2020) Discussion on the paper “Considerations of multiple imputation approaches for handling missing data in clinical trials”, by H Quan, L Qi, X Luo, and L Darchy. Contemporary Clinical Trials 89, pages 105917.
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Devan V Mehrotra. (2019) A note on the draft International Council for Harmonisation guidance on estimands and sensitivity analysis. Clinical Trials 16:4, pages 339-344.
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C. H. Mallinckrodt, J. Bell, G. Liu, B. Ratitch, M. O’Kelly, I. Lipkovich, P. Singh, L. Xu & G. Molenberghs. (2019) Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice. Therapeutic Innovation & Regulatory Science, pages 216847901983697.
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Suzie Cro, James R. Carpenter & Michael G. Kenward. (2019) Information-Anchored Sensitivity Analysis: Theory and Application. Journal of the Royal Statistical Society Series A: Statistics in Society 182:2, pages 623-645.
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Hui Quan, Li Qi, Xiaodong Luo & Loic Darchy. (2018) Considerations of multiple imputation approaches for handling missing data in clinical trials. Contemporary Clinical Trials 70, pages 62-71.
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Yongqiang Tang. (2017) On the multiple imputation variance estimator for control‐based and delta‐adjusted pattern mixture models. Biometrics 73:4, pages 1379-1387.
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Devan V. Mehrotra, Fang Liu & Thomas Permutt. (2017) Missing data in clinical trials: control-based mean imputation and sensitivity analysis. Pharmaceutical Statistics 16:5, pages 378-392.
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G. Frank Liu & James Kost. 2017. Monte-Carlo Simulation-Based Statistical Modeling. Monte-Carlo Simulation-Based Statistical Modeling 211 232 .

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