View Item 

Show simple item record

The design and conduct of clinical trials to limit missing data

dc.contributor.authorLittle, R. J.en_US
dc.contributor.authorCohen, M. L.en_US
dc.contributor.authorDickersin, K.en_US
dc.contributor.authorEmerson, S. S.en_US
dc.contributor.authorFarrar, J. T.en_US
dc.contributor.authorNeaton, J. D.en_US
dc.contributor.authorShih, W.en_US
dc.contributor.authorSiegel, J. P.en_US
dc.contributor.authorStern, H.en_US
dc.date.accessioned2012-12-11T17:37:15Z
dc.date.available2014-02-03T16:21:44Zen_US
dc.date.issued2012-12-10en_US
dc.identifier.citationLittle, R. J.; Cohen, M. L.; Dickersin, K.; Emerson, S. S.; Farrar, J. T.; Neaton, J. D.; Shih, W.; Siegel, J. P.; Stern, H. (2012). "The design and conduct of clinical trials to limit missing data." Statistics in Medicine 31(28): 3433-3443. <http://hdl.handle.net/2027.42/94446>en_US
dc.identifier.issn0277-6715en_US
dc.identifier.issn1097-0258en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/94446
dc.publisherJohn Wiley & Sons, Ltden_US
dc.subject.otherDropoutsen_US
dc.subject.otherClinical Trial Ethicsen_US
dc.subject.otherIncomplete Dataen_US
dc.subject.otherRandomized Withdrawalen_US
dc.subject.otherRun‐In Perioden_US
dc.titleThe design and conduct of clinical trials to limit missing dataen_US
dc.typeArticleen_US
dc.rights.robotsIndexNoFollowen_US
dc.subject.hlbsecondlevelPublic Healthen_US
dc.subject.hlbsecondlevelMedicine (General)en_US
dc.subject.hlbsecondlevelStatistics and Numeric Dataen_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.subject.hlbtoplevelScienceen_US
dc.subject.hlbtoplevelSocial Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.identifier.pmid22829439en_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/94446/1/sim5519.pdf
dc.identifier.doi10.1002/sim.5519en_US
dc.identifier.sourceStatistics in Medicineen_US
dc.identifier.citedreferenceKim Y. Missing data handling in chronic pain trials. Journal of Biopharmaceutical Statistics 2011; 21: 311 – 325.en_US
dc.identifier.citedreferenceU.S. Food and Drug Administration. Guidance for industry: antiretroviral drugs using plasma HIV; RNA measurements—clinical considerations for accelerated and traditional approval, 2002. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070968.pdf.en_US
dc.identifier.citedreferenceSquires K, Lazzarin A, Gatell JM, Powderly WG, Pokrovskiy V, Delfraissy JF, Jemsek J, Rivero A, Rozenbaum W, Schrader S, Sension M, Vibhagool A, Thiry A, Giordano M. Comparison of once‐daily atazanavir with efavirenz, each in combination with fixed‐dose zidovudine and lamivudine, as initial therapy for patients infected with HIV. Journal of Acquired Immune Deficiency Syndrome 2004; 36: 1011 – 1019.en_US
dc.identifier.citedreferenceMiller LW, Pagani FD, Russell SD, John R, Boyle AJ, Aaronson KD, Conte JV, Naka Y, Mancini D, Delgado RM, MacGillivray TE, Farrar DJ, Frazier OH. Use of continuous‐flow device in patients awaiting heart transplantations. New England Journal of Medicine 2007; 357: 885 – 896.en_US
dc.identifier.citedreferenceLavori PW, Brown CH, Duan N, Gibbons RD, Greenhouse J. Missing data in longitudinal clinical trials part A: design and conceptual issues. Psychiatric Annals 2008; 38: 784 – 792.en_US
dc.identifier.citedreferenceLakatos E. Sample sizes based on the logrank statistic in complex clinical trials. Biometrics 1988; 44: 229 – 241.en_US
dc.identifier.citedreferenceO'Neill RT. Missing data in clinical trials intended to support efficacy and safety of medical products: the need for consensus. 30th Annual Conference of the International Society for Clinical Biostatistics, Prague, Czech Republic, 2009. Available at: http://www.iscb2009.info/RSystem/Soubory/Prez%20Tuesday/S18.3%20O'Neill.pdf.en_US
dc.identifier.citedreferenceInternational Conference on Harmonisation. Efficacy Guideline E9. Dose‐Response Information to Support Drug Registration, 1994; 1 – 36. Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy‐guidelines.html.en_US
dc.identifier.citedreferenceEuropean Medicines Evaluation Agency. Guideline on Missing Data in Confirmatory Clinical Trials. Committee for Medical Products for Human Use, 2010; 1 – 12. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf.en_US
dc.identifier.citedreferenceInternational Conference on Harmonisation. Efficacy Guideline E4. Dose‐Response Information to Support Drug Registration, 1994; 1 – 10. Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy‐guidelines.html.en_US
dc.identifier.citedreferenceInternational Conference on Harmonisation. Efficacy Guidelines E10. Choice of Control Group and Related Issues in Clinical Trials, 2010; 1 – 29. Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy‐guidelines.html.en_US
dc.identifier.citedreferenceNational Research Council. The Prevention and Treatment of Missing Data in Clinical Trials. Panel on Handling Missing Data in Clinical Trials. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. The National Academies Press: Washington, DC, 2010.en_US
dc.identifier.citedreferenceHogan JW, Cohen ML, Little RJ, Molenberghs G, Rotnitsky A, Scharfstein D. The analysis of clinical trials with missing data. To be submitted to Statistics in Medicine.en_US
dc.identifier.citedreferenceMeinert CL. Toward more definitive clinical trials. Controlled Clinical Trials 1980; 1: 249 – 261.en_US
dc.identifier.citedreferenceDworkin RH, Turk DC, Peirce‐Sandner S, Baron R, Bellamy N, Burke LB, Chappell A, Chartier K, Cleeland CS, Costello A, Cowan P, Dimitrova R, Ellenberg S, Farrar JT, French JA, Gilron I, Hertz S, Jadad AR, Jay GW, Kalliomäki J, Katz NP, Kerns RD, Manning DC, McDermott MP, McGrath P, Narayana A, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Reeve B, Rhodes T, Sampaio C, Simpson DM, Stauffer JW, Stucki G, Tobias J, White RE, Witter J. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain 2010; 149: 177 – 193.en_US
dc.identifier.citedreferenceLeon AC, Hakan D, Hedeken D. Bias reduction with an adjustment for participants’ intent to dropout of a randomized controlled clinical trial. Clinical Trials 2007; 4: 540 – 547.en_US
dc.identifier.citedreferenceCommittee on Assessing the System for Protecting Human Research Participants. Responsible Research. A Systems Approach to Protecting Research Participants. Institute of Medicine. National Academy Press: Washington, DC, 2002.en_US
dc.identifier.citedreferenceEmmanuel EJ. Undue inducement: nonsense on stilts? American Journal of Bioethics 2005; 5 ( 5 ): 9 – 13.en_US
dc.identifier.citedreferenceDART Trial Team. Routine versus clinically driven laboratory monitoring of HIV antiretroviral therapy in Africa (DART): a randomized non‐inferiority trial. Lancet 2010; 375: 123 – 131.en_US
dc.identifier.citedreferenceNormand SL, Rector TS, Neaton JD, Pina IL, Lazar RM, Proestel SE, Fleischer DJ, Cohn JN, Spertus JA. Clinical and analytical considerations in the study of health status in device trials for heart failure. Journal of Cardiac Failure 2005; 11: 396 – 403.en_US
dc.identifier.citedreferenceRubin DB. Inference and missing data. Biometrika 1976; 63: 581 – 592.en_US
dc.identifier.citedreferenceShih JH. Sample size calculation for complex clinical trials with survival endpoints. Controlled Clinical Trials 1995; 16 ( 6 ): 395 – 407.en_US
dc.owningcollnameInterdisciplinary and Peer-Reviewed


Files in this item

Name:
sim5519.pdf
Size:
121.6KB
Format:
PDF
View/Open

Show simple item record

Remediation of Harmful Language

The University of Michigan Library aims to describe library materials in a way that respects the people and communities who create, use, and are represented in our collections. Report harmful or offensive language in catalog records, finding aids, or elsewhere in our collections anonymously through our metadata feedback form. More information at Remediation of Harmful Language.

Accessibility

If you are unable to use this file in its current format, please select the Contact Us link and we can modify it to make it more accessible to you.