临床试验词汇汇编

临床试验词汇汇编GlossaryofClinicalTrialsTermsThefollowingglossarywaspreparedtohelptheconsumerbecomefamiliarwithmanyofthecommontermsusedinclinicaltrials.以下汇编为帮助顾客熟悉一些常用的用于临床试验的词汇ADVERSEREACTION不良反应（不良事件）:(AdverseEvent.)Anunwantedeffectcausedbytheadministrationofdrugs.Onsetmaybesuddenordevelopovertime(SeeSideEffects).由应用药物引起的意外的效果，可以突然出现或随时间的推移而进展（见SideEffects）。ADVOCACYANDSUPPORTGROUPS倡导和支持的群体:Organizationsandgroupsthatactivelysupportparticipantsandtheirfamilieswithvaluableresources,includingself-empowermentandsurvivaltools.积极支持与会者和他们熟悉的有利的资源，包括自强和生存工具。APPROVEDDRUGS批准的药物:IntheU.S.,theFoodandDrugAdministration(FDA)mustapproveasubstanceasadrugbeforeitcanbemarketed.Theapprovalprocessinvolvesseveralstepsincludingpre-clinicallaboratoryandanimalstudies,clinicaltrialsforsafetyandefficacy,filingofaNewDrugApplicationbythemanufacturerofthedrug,FDAreviewoftheapplication,andFDAapproval/rejectionofapplication(SeeFoodandDrugAdministration).在美国，食品药品监督管理局(FDA)在药品上市之前必须批准药物成分。审批程序包括几步：包括临床前期的实验室和动物研究，安全性和有效性的动物实验，由药物生产企业提交一份新药申请，FDA审阅申请，通过/拒绝申请。（见FoodandDrugAdministration）ARM组:Anyofthetreatmentgroupsinarandomizedtrial.Mostrandomizedtrialshavetwoarms,butsomehavethreearms,orevenmore(SeeRandomizedTrial).任何治疗组均在一个随机试验中。大部分随机试验有两个“臂”，但有一些有三个甚至更多（见RandomizedTrial）BASELINE基准:1.研究初期的信息搜集，从这些变化中发现研究的衡量。Informationgatheredatthebeginningofastudyfromwhichvariationsfoundinthestudyaremeasured.2.一个已知的价值或数量与一个不明的可以对比衡量和评估。Aknownvalueorquantitywithwhichanunknowniscomparedwhenmeasuredorassessed.3.在临床试验初期的试验点，试验者开始接收被测试的实验治疗之前，在这个参考点，例如评估CD4计数，确定药物安全性和有效性，是监测基线水平的变化。Theinitialtimepointinaclinicaltrial,justbeforeaparticipantstartstoreceivetheexperimentaltreatmentwhichisbeingtested.Atthisreferencepoint,measurablevaluessuchasCD4countarerecorded.Safetyandefficacyofadrugareoftendeterminedbymonitoringchangesfromthebaselinevalues.BIAS偏向:当一个观点阻止在相关科目的观点议题上公正的判断，在临床研究中，采用盲法和随机化控制偏向。（见BlindandRandomization）Whenapointofviewpreventsimpartialjudgmentonissuesrelatingtothesubjectofthatpointofview.Inclinicalstudies,biasiscontrolledbyblindingandrandomization(See).BLIND盲法:一个随机的试验是设盲的，如果受试者不被告诉位于试验的哪一方。在临床试验中是设盲的，受试者是不确定在研究的实验组还是控制组，也叫蒙蔽。ArandomizedtrialisBlindiftheparticipantisnottoldwhicharmofthetrialheison.AclinicaltrialisBlindifparticipantsareunawareonwhethertheyareintheexperimentalorcontrolarmofthestudy;alsocalledmasked.(SeeSingleBlindStudyandDoubleBlindStudy).CLINICAL临床:Pertainingtoorfoundedonobservationandtreatmentofparticipants,asdistinguishedfromtheoreticalorbasicscience.受试者有关的或基础的观察和治疗，作为杰出的理论和基础科学。CLINICALENDPOINT临床终点:SeeEndpoint.CLINICALINVESTIGATOR临床调查员:一位负责实施临床试验议定书的医学研究员。Amedicalresearcherinchargeofcarryingoutaclinicaltrial'sprotocol.CLINICALTRIAL临床试验:临床试验是一项回答关于疫苗、新方法或利用已知方法的新途径等专门问题的项目。临床试验（也叫医学研究）用于确定新药或治疗方法是否安全有效，仔细开展临床试验是发现对人体有作用的治疗方法的最快、最安全的途径。试验分四阶段：Ⅰ阶段在小群体中测试新药或治疗方法；Ⅱ阶段在一个较大的群体中扩大研究；Ⅲ阶段在一个相当大的群体中扩大研究；Ⅳ新药或治疗方法被批准和投入市场后发生的情况。clinicaltrialisaresearchstudytoanswerspecificquestionsaboutvaccinesornewtherapiesornewwaysofusingknowntreatments.Clinicaltrials(alsocalledmedicalresearchandresearchstudies)areusedtodeterminewhethernewdrugsortreatmentsarebothsafeandeffective.Carefullyconductedclinicaltrialsarethefastestandsafestwaytofindtreatmentsthatworkinpeople.Trialsareinfourphases:PhaseItestsanewdrugortreatmentinasmallgroup;PhaseIIexpandsthestudytoalargergroupofpeople;PhaseIIIexpandsthestudytoanevenlargergroupofpeople;andPhaseIVtakesplaceafterthedrugortreatmenthasbeenlicensedandmarketed.(SeePhaseI,II,III,andIVTrials).COHORT队列:Inepidemiology,agroupofindividualswithsomecharacteristicsincommon.在流行病学，一组具有医学共同特征的个体。COMMUNITY-BASEDCLINICALTRIAL以社区为基础的临床试验(CBCT):Aclinicaltrialconductedprimarilythroughprimary-carephysiciansratherthanacademicresearchfacilities.主要是通过初级保健医师开展，而不是学术研究设施的临床试验。COMPASSIONATEUSE使用同情:AmethodofprovidingexperimentaltherapeuticspriortofinalFDAapprovalforuseinhumans.Thisprocedureisusedwithverysickindividualswhohavenoothertreatmentoptions.Often,case-by-caseapprovalmustbeobtainedfromtheFDAforcompassionateuseofadrugortherapy.最后提交FDA同意用于人体前，提供的一种实验治疗方法，这一过程用于没有其它可以选择的治疗方法的病人。经常必须逐个同意获得FDA的药物或治疗的安慰剂治疗。COMPLEMENTARYANDALTERNATIVETHERAPY补充和替代治疗:Broadrangeofhealingphilosophies,approaches,andtherapiesthatWestern(conventional)medicinedoesnotcommonlyusetopromotewell-beingortreathealthconditions.Examplesincludeacupuncture,herbs,etc.InternetAddress:广泛的愈合理念，方法和西方常规医学不能用于提高或改善健康状况的疗法。包括：针灸、草药等网址补充:SeeRecruitmentStatusCONFIDENTIALITYREGARDINGTRIALPARTICIPANTS关于受试者保密:Referstomaintainingtheconfidentialityoftrialparticipantsincludingtheirpersonalidentityandallpersonalmedicalinformation.Thetrialparticipants'consenttotheuseofrecordsfordataverificationpurposesshouldbeobtainedpriortothetrialandassurancemustbegiventhatconfidentialitywillbemaintained.指的是维护受试者的保密性，包括他们的个人身份和个人的医学信息。试验之前应当获得受试者的同意使用记录的数据核查的目的，并保证必要的保密性将保持不变。指的是CONTRAINDICATION禁忌:Aspecificcircumstancewhentheuseofcertaintreatmentscouldbeharmful.在特定的环境中当使用某种治疗可能是有害的。CONTROL对照:Acontrolisthenatureoftheinterventioncontrol.对照的本质是干预对照。CONTROLGROUP对照组:Thestandardbywhichexperimentalo