Room for Improvement in Conducting and Reporting Non-Inferiority Randomized Controlled Trials on Drugs A Systematic Review 英文参考文献.docVIP

Room for Improvement in Conducting and Reporting Non-Inferiority Randomized Controlled Trials on Drugs A Systematic Review 英文参考文献.doc

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Room for Improvement in Conducting and Reporting Non-Inferiority Randomized Controlled Trials on Drugs A Systematic Review 英文参考文献

RoomforImprovementinConductingandReporting Non-InferiorityRandomizedControlledTrialsonDrugs:A SystematicReview GraceWangge1,OlafH.Klungel1,KitC.B.Roes2,AnthoniusdeBoer1,ArnoW.Hoes1,MirjamJ.Knol1,2* 1Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands, 2UniversityMedicalCenterUtrecht,JuliusCenterforHealthSciencesandPrimaryCare,Utrecht,TheNetherlands Abstract Background: A non-inferiority (NI) trial is intended to show that the effect of a new treatment is not worse than the comparator. We conducted a review to identify how NI trials were conducted and reported, and whether the standard requirementsfromtheguidelineswerefollowed. MethodologyandPrincipalFindings:From300randomlyselectedarticlesonNItrialsregisteredinPubMedat5February 2009, we included 227 NI articles that referred to 232 trials. We excluded studies on bioequivalence, trials on healthy volunteers, non-drug trials, andarticles of which the full-text version could not be retrieved. A large proportion of trials (34.0%)didnotuseblinding.TheNImarginwasreportedin97.8%ofthetrials,butonly45.7%ofthetrialsreportedthe methodtodeterminethemargin.Mostofthetrialsusedeitherintentiontotreat(ITT)(34.9%)orper-protocol(PP)analysis (19.4%),while41.8%ofthetrialsusedbothmethods.Lessthan10%ofthetrialsincludedaplaceboarmtoconfirmthe efficacyofthenewdrugandactivecomparatoragainstplacebo,andlessthan5.0%werereportingthesimilarityofthe currenttrialwiththepreviouscomparator’strials.Ingeneral,nodifferencewasseeninthequalityofreportingbeforeand afterthereleaseoftheCONSORTstatementextension2006orbetweenthehigh-impactandlow-impactjournals. Conclusion:TheconductandreportingofNItrialscanbeimproved,particularlyintermsofmaximizingtheuseofblinding, the use of both ITT and PP analysis, reporting the similarity with the previous comparator’s trials to guarantee a valid constancyassumption,andmostimportantlyreportingthemethodtodeterminethe

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