SPIRIT-2013声明-定义临床研究方案的标准条目

SPIRIT2013声明:定义临床研究方案的标准条目作者：钟丽丹，郑颂华，吴泰相，李幼平，商洪才，张伯礼，唐旭东，吕爱平，卞兆祥作者单位：SPIRIT中文工作组刊名：中国中西医结合杂志英文刊名：ChineseJournalofIntegratedTraditionalandWesternMedicine年，卷(期)：2014,34(1)参考文献(51条)1.RennieDTrialregistration:agreatideaswitchesfromignoredtoirresistible2004(11)2.DeAngelisCD;FontanarosaPBStrengtheningthecredibilityofclinicalresearch2010(9722)3.SummerskillW;CollingridgeD;FrankishHProtocols,probity,andpublication2009(9668)4.JonesG;AbbasiKTrialprotocolsattheBMJ2004(9668)5.GrovesTLetSPIRITtakeyou...towardsmuchclearertrialprotocols20126.AltmanDG;FurbergCD;GrimshawJMLeadeditorial:trials-usingtheopportunitiesofelectronicpublishingtoimprovethereportingofrandomisedtrials2006(23)7.TurnerEHAtaxpayer-fundedclinicaltrialsregistryandresultsdatabase2004(3)8.CoultasDEthicalconsiderationsintheinterpretationandcommunicationofclinicaltrialresults2007(2)9.SiegelJPEditorialreviewofprotocolsforclinicaltrials1990(19)10.MurrayGDResearchgovernancemustfocusonresearchtraining2001(7300)11.ChanAWAccesstoclinicaltrialdata2011(342)12.MillerJDRegisteringclinicaltrialresults:thenextstep2010(8)13.Krlezνa-Jeric'K;ChanAW;DickersinKPrinciplesforinternationalregistrationofprotocolinformationandresultsfromhumantrialsofhealthrelatedinterventions:OttawaStatement(Part1)2005(7497)14.LassereM;JohnsonKThepoweroftheprotocol2002(9346)15.GetzKA;ZuckermanR;CroppABMeasuringtheincidence,causes,andrepercussionsofprotocolamendments201116.PublicCitizenHealthResearchGroupFoodandDrugAdministration199717.TetzlaffJM;ChanAW;KitchenJGuidelinesforrandomizedclinicaltrialprotocolcontent:asystematicreview201218.ChanAW;Hro'bjartssonA;HaahrMTEmpiricalevidenceforselectivereportingofoutcomesinrandomizedtrials:comparisonofprotocolstopublishedarticles2004(20)19.SmythRM;KirkhamJJ;JacobyAFrequencyandreasonsforoutcomereportingbiasinclinicaltrials:interviewswithtrialists201120.PildalJ;ChanAW;Hro'bjartssonAComparisonofdescriptionsofallocationconcealmentintrialprotocolsandthepublishedreports:cohortstudy2005(7499)21.MhaskarR;DjulbegovicB;MagazinAPublishedmethodologicalqualityofrandomizedcontrolledtrialsdoesnotreflecttheactualqualityassessedinprotocols2012(6)22.Hro'bjartssonA;PildalJ;ChanA-WReportingonblindingintrialprotocolsandcorrespondingpublicationswasofteninadequatebutrarelycontradictory2009(9)23.ScharfO;ColevasADAdverseeventreportinginpublicationscomparedwithsponsordatabaseforcancerclinicaltrials2006(24)24.ChanAW;Hro'bjartssonA;JφrgensenKJDiscrepanciesinsamplesizecalculationsanddataanalysesreportedinrandomizedtrials:comparisonofpublicationswithprotocols200825.AI-MarzoukiS;RobertsI;EvansSSelectivereportinginclinicaltrials:analysisoftrialprotocolsacceptedbyTheLancet2008(9634)26.Herna'ndezAV;SteyerbergEW;TaylorGSSubgroupanalysisandcovariateadjustmentinrandomizedclinicaltrialsoftraumaticbraininjury:asystematicreview2005(6)27.GφtzschePC;Hro'bjartssonA;JohansenHKConstraintsonpublicationrightsinindustry-initiatedclinicaltrials2006(14)28.GφtzschePC;Hro'bjartssonA;JohansenHKGhostauthorshipinindustry-initiatedrandomizedtrials2007(1)29.LundhA;KrogsbφllLT;GφtzschePCAccesstodatainindustry-sponsoredtrials2011(9808)30.HopewellS;DuttonS;YuLMThequalityofreportsofrandomizedtrialsin2000and2006:comparativestudyofarticlesindexedinPubMed201031.ChanAW;TetzlaffJM;GφtzschePCSPIRIT2013explanationandelaboration:guidanceforprotocolsofclinicaltrials201332.MoherD;SchulzKF;SimeraIGuidancefordevelopersofhealthresearchreportingguidelines201033.TetzlaffJM;MoherD;ChanAWDevelopingaguidelineforclinicaltrialprotocolcontent:Delphiconsensussurvey201234.WorldMedicalAssociationWMADeclarationofHelsinki-EthicalPrinciplesforMedicalResearchInvolvingHumanSubjects201235.InternationalConferenceonHarmonisationICHHarmonizedTripartiteGuideline:GeneralConsiderationsforClinicalTrials:E8.InternationalConferenceonHarmonisationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse.17July,1997201236.InternationalConferenceonHarmonisationICHHarmonisedTripartiteGuideline:StatisticalPrinciplesforClinicalTrials:E9.InternationalConferenceonHarmonisationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse.5February,1998201237.InternationalConferenceonHarmonisationICHHarmonisedTripartiteGuideline:GuidelineforGoodClinicalPractice:E6.InternationalConferenceonHarmonisationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse.10June,1996201238.GrimesDA;HubacherD;NandaKTheGoodClinicalPracticeguideline:abronzestandardforclinicalresearch2005(9480)39.SimI;ChanAW;Gu'lmezogluAMClinicaltrialregistration:transparencyisthewatchword2006(9523)40.LaineC;DeAngelisC;DelamotheTClinicaltrialregistration:lookingbackandmovingahead200741.FoodandDrugAdministrationAmendmentsActof2007,HR2580,110thCongress,1stSess,TitleⅧ,§801(2007).ExpandedClinicalTrialRegistryDataBank201242.EuropeanCommissionCommunicationfromtheCommissionregardingtheguidelineonthedatafieldscontainedintheclinicaltrialsdatabaseprovidedforinArticle11ofDirective2001/20/ECtobeincludedinthedatabaseonmedicinalproductsprovidedforinArticle57ofRegulation(EC)No726/2004(2008/C168