Publication of Clinical Trials Supporting Successful New Drug Applications A Literature Analysis 英文参考文献.docVIP

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Publication of Clinical Trials Supporting Successful New Drug Applications A Literature Analysis 英文参考文献.doc

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Publication of Clinical Trials Supporting Successful New Drug Applications A Literature Analysis 英文参考文献

o PL SMEDICINE PublicationofClinicalTrialsSupporting SuccessfulNewDrugApplications: ALiteratureAnalysis Kirby Lee1,Peter Bacchetti2,Ida Sim3* 1DepartmentofClinicalPharmacy,UniversityofCaliforniaSanFrancisco,SanFrancisco,California,UnitedStatesofAmerica,2DepartmentofEpidemiologyandBiostatistics, UniversityofCaliforniaSanFrancisco,SanFrancisco,California,UnitedStatesofAmerica,3DivisionofGeneralInternalMedicine,UniversityofCaliforniaSanFrancisco,San Francisco,California,UnitedStatesofAmerica Funding:Theprojectdescribedwas supportedinpartbyfundsfromthe UnitedStatesPresidentialEarly CareerAwardforScientistsand EngineersawardedtoISand ABSTRACT Background administeredundergrantLM-06780, andbyNationalInstitutesofHealth/ NationalCenterforResearch Resources(NIH/NCRR)Universityof CaliforniaSanFrancisco–Clinicaland TranslationalScienceInstitute(UCSF- CTSI).GrantnumberUL1RR024131 andgrantnumberKL2RR024130to KL.Itscontentsaresolelythe TheUnitedStates(US)FoodandDrugAdministration(FDA)approvesnewdrugsbasedon sponsor-submittedclinicaltrials.Thepublicationstatusofthesetrialsinthemedicalliterature andfactorsassociatedwithpublicationhavenotbeenevaluated.Wesoughttodeterminethe proportion of trials submitted to the FDA in support of newly approved drugs that are publishedinbiomedicaljournalsthatatypicalclinician,consumer,orpolicymakerlivinginthe USwouldreasonablysearch. responsibilityoftheauthorsanddo notnecessarilyrepresenttheofficial viewsoftheNIH.Thegranting agencieshadnoroleinthedesign, conduct,review,orpublication approvalofthisstudy. MethodsandFindings Weconductedacohortstudyoftrialssupportingnewdrugsapprovedbetween1998and 2000, as described in FDA medical and statistical review documents and the FDA approved druglabel.Wedeterminedpublicationstatusandtimefromapprovaltofullpublicationinthe medicalliteratureat2and5ybysearchingPubMedandotherdatabasesthrough01August 2006. We then evaluated trial characteristics associated with publication. We identified 909 trials supporting 90 appro