Reporting Bias in Drug Trials Submitted to the Food and Drug Administration Review of Publication and Presentation 英文参考文献.docVIP

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Reporting Bias in Drug Trials Submitted to the Food and Drug Administration Review of Publication and Presentation 英文参考文献.doc

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Reporting Bias in Drug Trials Submitted to the Food and Drug Administration Review of Publication and Presentation 英文参考文献

o PL SMEDICINE ReportingBiasinDrugTrialsSubmitted totheFoodandDrugAdministration: ReviewofPublicationandPresentation Kristin Rising1¤,Peter Bacchetti2,Lisa Bero3* 1SchoolofMedicine,UniversityofCaliforniaSanFrancisco,SanFrancisco,California,UnitedStatesofAmerica,2DepartmentofEpidemiologyandBiostatistics,Universityof California San Francisco, San Francisco,California, United States of America, 3 Clinical Pharmacy and Health Policy, University of California San Francisco,San Francisco, California,UnitedStatesofAmerica Funding:Thispublicationwas supportedbyNIH/NCRRUCSF-CTSI GrantNumberUL1RR024131.Its contentsaresolelytheresponsibility oftheauthorsanddonot ABSTRACT Background necessarilyrepresenttheofficial viewsoftheNIH.Thesponsorplayed noroleinthedesign,conduct, analysisofthisresearch,decisionto submitthearticle,orpreparationof thearticle. Previousstudiesofdrugtrialssubmittedtoregulatoryauthoritieshavedocumentedselective reportingofbothentiretrialsandfavorableresults.Theobjectiveofthisstudyistodetermine thepublicationrateofefficacytrialssubmittedtotheFoodandDrugAdministration(FDA)in approvedNewDrugApplications(NDAs)andtocomparethetrialcharacteristicsasreportedby theFDAwiththosereportedinpublications. CompetingInterests:Theauthors havedeclaredthatnocompeting interestsexist. MethodsandFindings AcademicEditor:JohnIoannidis, UniversityofIoannina,Greece ThisisanobservationalstudyofallefficacytrialsfoundinapprovedNDAsforNewMolecular Entities(NMEs)from2001to2002inclusiveandallpublishedclinicaltrialscorrespondingtothe trialswithintheNDAs.ForeachtrialincludedintheNDA,weassesseditspublicationstatus, primary outcome(s)reportedandtheirstatistical significance,andconclusions. Seventy-eight percent (128/164) of efficacy trials contained in FDA reviews of NDAs were published. In a multivariatemodel,trialswithfavorableprimaryoutcomes(OR?4.7,95%confidenceinterval [CI]1.33–17.1,p?0.018)andactivecontrols(OR?3.4,95%CI1.02–11.2,p?0.047)weremore likely to be published. Forty-one primary