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