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Analyzing clinical trial outcomes based on incomplete daily diary reports
dc.contributor.authorThomas, Neal
dc.contributor.authorHarel, Ofer
dc.contributor.authorLittle, Roderick J.A.
dc.date.accessioned2016-07-06T18:22:01Z
dc.date.available2017-09-06T14:20:20Zen
dc.date.issued2016-07-30
dc.identifier.citationThomas, Neal; Harel, Ofer; Little, Roderick J.A. (2016). "Analyzing clinical trial outcomes based on incomplete daily diary reports." Statistics in Medicine 35(17): 2894-2906.
dc.identifier.issn0277-6715
dc.identifier.issn1097-0258
dc.identifier.urihttps://hdl.handle.net/2027.42/122440
dc.publisherThe National Academies Press
dc.publisherWiley Periodicals, Inc.
dc.subject.othermultiple imputation
dc.subject.otherpattern mixture models
dc.subject.otherclinical trials
dc.subject.otherincomplete data
dc.titleAnalyzing clinical trial outcomes based on incomplete daily diary reports
dc.typeArticleen_US
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelStatistics and Numeric Data
dc.subject.hlbsecondlevelPublic Health
dc.subject.hlbsecondlevelMedicine (General)
dc.subject.hlbtoplevelScience
dc.subject.hlbtoplevelSocial Sciences
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/122440/1/sim6890.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/122440/2/sim6890-sup-0001-supplementary.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/122440/3/sim6890_am.pdf
dc.identifier.doi10.1002/sim.6890
dc.identifier.sourceStatistics in Medicine
dc.identifier.citedreferenceGiusti C, Little R. An analysis of nonignorable nonresponse to income in a survey with a rotating panel design. Journal of Official Statistics. 2011; 27 ( 2 ): 211 – 229.
dc.identifier.citedreferenceAyele B, Lipkovich I, Molenberghs G, Mallinckrodt C. A multiple‐imputation‐based approach to sensitivity analyses and effectiveness assessments in longitudinal clinical trials. Journal of Biopharmaceutical Statistics. 2014; 24 ( 2 ): 211 – 228.
dc.identifier.citedreferenceSiddique J, Harel O, Crespi C. Addressing missing data mechanism uncertainty using multiple‐model multiple imputation: application to a longitudinal clinical trial. The Annals of Applied Statistics. 2012; 6 ( 4 ): 1814 – 1837.
dc.identifier.citedreferenceLittle R. Missing data adjustments in large surveys (with discussion). Journal of Business Economics and Statistics. 1988; 6: 287 – 301.
dc.identifier.citedreferenceFood, Administration D. Suvorexant advisory committee meeting briefing document, 2013. Available from: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/peripheralandcentralnervoussystemdrugsadvisorycommittee/ucm352970.pdf [Accessed on May 2015].
dc.identifier.citedreferenceSchafer J, Yucel R. Computational strategies for multivariate linear mixed effects models with missing values. Journal of Computational and Graphical Statistics. 2002; 11: 437 – 457.
dc.identifier.citedreferenceZhao J, Schafer J. pan: multiple imputation for multivariate panel or clustered data, 2013. R package version 0.9.
dc.identifier.citedreferenceStan Development Team. Stan: A C++ Library for Probability and Sampling, 2013. Available from: http://mc-stan.org/, 1.3 edn. [Accessed on May 2015].
dc.identifier.citedreferenceCochran W. Sampling Techniques ((3rd edn)). Wiley: New York, 1977.
dc.identifier.citedreferenceLittle R. Pattern‐mixture models for multivariate incomplete data. Journal of the American Statistial Association. 1993; 88 ( 421 ): 125 – 134.
dc.identifier.citedreferenceLittle R, Yau L. Intent‐to‐treat analysis for longitudinal studies with drop‐outs. Biometrics. 2006; 52 ( 4 ): 1324 – 1333.
dc.identifier.citedreferenceCarpenter J, Roger J, Kenward M. Analysis of longitudinal trials with protocol deviation: a framework for relevant, accessible assumptions, and inference via multiple imputation. Journal of Biopharmaceutical Statistics. 2013; 23 ( 4 ): 1352 – 1371.
dc.identifier.citedreferenceWickam H. ggplot2: Elegant Graphics for Data Analysis. Springer: New York, 2009. Available from: http://had.co.nz/ggplot2/book [Accessed on May 2015].
dc.identifier.citedreferenceR Development Core Team. R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing: Vienna, Austria, 2011.
dc.identifier.citedreferencePreisser JS, Lohman KK, Rathouz P. Performance of weighted estimating equations for longitudinal winary data with drop‐outs missing at random. Statistics in Medicine. 2002; 21: 3035 – 3054.
dc.identifier.citedreferenceRobins J, Rotnitzky A. Semiparametric efficiency in multivariate regression models with missing data. Journal of American Statistical Association. 1995; 90: 122 – 129.
dc.identifier.citedreferenceNational Research Council. The Prevention and Treatment of Missing Data in Clinical Trials. The National Academies Press: Washington, DC, 2010.
dc.identifier.citedreferenceLittle R, D'Agostino R, Cohen M, Dickersin K, Emerson S, Farrar J, Frangakis C, Hogan J, Molenberghs G, Murphy S, Neaton J, Rotnitzky A, Scharfstein D, Shih W, Siegel J, Stern H. Special report: the prevention and treatment of missing data in clinical trials. New England Journal of Medicine. 2012; 367 ( 14 ): 1355 – 1360.
dc.identifier.citedreferenceRubin D. Inference and missing data. Biometrika. 1976; 63 ( 3 ): 581 – 592.
dc.identifier.citedreferenceRubin D. Multiple Imputation for Nonresponse in Surveys. Wiley: New York, 1987.
dc.identifier.citedreferenceLittle R, Kang S. Intention‐to‐treat analysis with treatment discontinuation and missing data in clinical trials. Statistics in Medicine. 2015; 34 ( 16 ): 2381 – 2390.
dc.identifier.citedreferenceRatitch B, O'Kelly M, Tosiello R. Missing data in clinical trials: from clinical assumptions to statistical analysis using pattern mixture models. Pharmaceutical Statistics. 2013; 12 ( 6 ): 337 – 347.
dc.identifier.citedreferenceZhang J, Rubin DB. Estimation of causal effects via principal stratification when some outcomes are truncated by death. Journal of Educational and Behavioral Statistics. 2003; 28 ( 4 ): 353 – 368.
dc.identifier.citedreferenceMerck Sharp & Dohme Corp. Safety and efficacy study of suvorexant in participants with primary insomnia (mk‐4305‐028). ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US), 2015. Available from: https://clinicaltrials.gov/ct2/show/NCT01097616NLMIdentifier:NCT01097616 2000‐[Access on 5 March 2015].
dc.identifier.citedreferenceFarrar J, Young J, LaMoreaux L, Werth J, Poole M. Clinical importance of changes in chronic pain intensity measured on an 11‐point numerical pain rating scale. Pain. 2001; 94: 149 – 158.
dc.identifier.citedreferenceTempl M, Alfons A, Kowarik A, Prantner B. VIM: Visualization and imputation of missing values, 2013. Available from: http://CRAN.R-project.org/package=VIM, r package version 4.0.0 [Accessed on May 2015].
dc.identifier.citedreferenceIliadis A, Macheras P. Modeling in Biopharmaceutics, and Pharmacodynamics: Homogeneous and Heterogeneous Approaches. Springer: New York, 2006.
dc.identifier.citedreferenceThomas N, Sweeney K, Somayaji V. Meta‐analysis of clinical dose–response in a large drug development portfolio. Statistics in Biopharmaceutical Research. 2014; 6 ( 4 ): 302 – 317.
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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