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Original Articles

An Efficient Multiple Imputation Algorithm for Control-Based and Delta-Adjusted Pattern Mixture Models using SAS

Pages 116-125 | Received 01 Dec 2015, Published online: 02 Mar 2017

References

  • Ayele, B. T., Lipkovich, I., Molenberghs, G., and Mallinckrodt, C. H. (2014), “A Multiple-Imputation-Based Approach to Sensitivity Analyses and Effectiveness Assessments in Longitudinal Clinical Trials,” Journal of Biopharmaceutical Statistics, 24, 211–228.
  • Carpenter, J., Roger, J., and Kenward, M. (2013), “Analysis of Longitudinal Trials with Protocol Deviation: A Framework for Relevant, Accessible Assumptions, and Inference Via Multiple Imputation,” Journal of Biopharmaceutical Statistics, 23, 1352–1371.
  • CHMP (2010), EMA Guideline on Missing Data in Confirmatory Clinical Trials (EMA/CPMP/EWP/1776/99), London: CHAMP.
  • ICH E9 (1999), “Statistical Principles for Clinical Trials: ICH Harmonized Tripartite Guideline,” Statistics in Medicine, 18, 1905–1942.
  • Little, R. and Yau, L. (1996), “Intent-to-Treat Analysis for Longitudinal Studies with Drop-outs,” Biometrics, 52, 1324–1333.
  • Liu, J. S. (1994), “The Collapsed Gibbs Sampler in Bayesian Computations with Applications to a Gene Regulation Problem,” Journal of the American Statistical Association, 89, 958–966.
  • Lu, K. (2014a), “An Analytic Method for the Placebo-Based Pattern-mixture Model,” Statistics in Medicine, 33, 1134–1145.
  • ——— (2014b), “An Extension of the Placebo-Based Pattern-Mixture Model,” Pharmaceutical Statistics, 13, 103–109.
  • Mallinckrodt, C., Roger, J., Chuang-stein, C., Molenberghs, G., Lane, P. W., O’kelly, M., Ratitch, B., Xu, L., Gilbert, S., Mehrotrak, D. V., Wolfinger, R., and Thijs, H. (2013), “Missing Data: Turning Guidance Into Action,” Statistics in Biopharmaceutical Research, 5, 369–382.
  • Meng, X. (1994), “Multiple-Imputation Inference with Uncongenial Sources of Input,” Statistical Science, 9, 538–573.
  • National Research Council (2010), The Prevention and Treatment of Missing Data in Clinical Trials, Washington, DC: The National Academies Press.
  • Phillips, A., Abellan-Andres, J., Soren, A., Bretz, F., Fletcher, C., France, L., Garrett, A., Harris, R., Kjaer, M., Keene, O., Morgan, D., and James Roger, M. O. (2016), “Estimands: Discussion Points from the psi Estimands and Sensitivity Expert Group,” Pharmaceutical Statistics, DOI: 10.1002/pst.1745.
  • Ratitch, B. and O’Kelly, M. (2011), “Implementation of Pattern-mixture Models Using Standard SAS/STAT Procedures,” in Proceedings of PharmaSUG 2011 (Pharmaceutical Industry SAS Users Group), SP04, Nashville, TN.
  • Ratitch, B., O’Kelly, M., and Tosiello, R. (2013), “Missing Data in Clinical Trials: from Clinical Assumptions to Statistical Analysis Using Pattern Mixture Models,” Pharmaceutical Statistics, 12, 337–347.
  • Rubin, D. (1987), Multiple Imputation for Nonresponse in Surveys, New York: Wiley.
  • Schafer, J. L. (1997), Analysis of Incomplete Multivariate Data, London: Chapman Hall.
  • Siddiqui, O., Hung, J. H. M., and O’Neill, R. (2009), “MMRM vs. LOCF: A Comprehensive Comparison Based on Simulation Study and 25 NDA Datasets,” Journal of Biopharmaceutical Statistics, 19, 227–246.
  • Tang, Y. (2015), “An Efficient Monotone data Augmentation Algorithm for Bayesian Analysis of Incomplete Longitudinal Data,” Statistics and Probability Letters, 104, 146–152.
  • ——— (2016), “An Efficient Monotone data Augmentation Algorithm for Multiple Imputation in a Class of Pattern Mixture Models,” Journal of Biopharmaceutical Statistics, DOI: 10.1080/10543406.2016.1167075.
  • ——— (2017), “On the Multiple Imputation Variance Estimator for Control-Based and Delta-Adjusted Pattern Mixture Models,” Biometrics, submitted.
  • van Buuren, S. (2007), “Multiple Imputation of Discrete and Continuous Data by Fully Conditional Specification,” Statistical Methods in Medical Research, 16, 219–242.

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