clinical trial
clinical-trials-临床试验方案 PPT课件
• Cohort Study: Persons w/ and/or w/out disease are followed over time
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Terminology (Cont.)
Studies”
Epidemiology often is defined as: The study of the distribution of a disease or condition in a population and the factors that influence that distribution.
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Classifications of Research Studies: Three Main Types
Observational Studies: • Groups are studied & contrasts made between groups • The observed data collected are analyzed Analytic Studies: • Also called Experimental • Study the impact of a certain therapy • Ultimately the investigator controls factor being studied Clinical Trial: • Considered the “true” experimental study • “Gold Standard” of clinical research • Often a prospective study that compares the effect and value
clinical trail的分类与区别
clinical trail的分类与区别
临床试验(Clinical Trial)是指以人体(正常人或患者)为研究对象，在受试者(或其监护人)知情同意、监管部门依法管理、科学家严格控制的条件下所开展的系统性、干预性科学研究，以探索或证实试验用药品、器械或新的治疗方案等对人体的作用、不良反应，目的是确认试验药品、器械、治疗方法等的效果及安全性。
临床试验一般分为I、II、III、IV期临床试验和EAP临床试验。
临床试验与全球同步的新药临床试验研究和国外已上市，按国家相关法律法规要求在国内开展的临床试验研究是不同的。
药物临床试验英文词汇及缩写
药物临床试验英文缩写.药物临床试验英文缩写.......实验室检查英文缩写..Accuracy 准确度Active control， AC 阳性对照，活性对照Adverse drug reaction， ADR 药物不良反应Adverse event， AE 不良事件Adverse medical events 不良医学事件Adverse reaction 药物不良反应Alb 白蛋白ALD（Approximate Lethal Dose）近似致死剂量ALP 碱性磷酸酶Alpha spending function 消耗函数ALT 丙氨酸氨基转换酶Analysis sets 统计分析的数据集Approval 批准Assistant investigator 助理研究者AST 天门冬酸氨基转换酶ATR 衰减全反射法AUCss 稳态血药浓度－时间曲线下面积Audit 稽查Audit or inspection 稽查／视察Audit report 稽查报告Auditor 稽查员Bias 偏性，偏倚Bioequivalence 生物等效应Blank control 空白对照Blind codes 编制盲底Blind review 盲态审核Blind review 盲态检查Blinding method 盲法Blinding/ masking 盲法，设盲Block 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form， CRF 病例报告表，病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL 清除率Clinical equivalence 临床等效应Clinical study 临床研究Clinical study report 临床试验的总结报告Clinical trial 临床试验Clinical trial application， CTA 临床试验申请Clinical trial exemption， CTX 临床试验免责Clinical trial protocol， CTP 临床试验方案Clinical trial/ study report 临床试验报告Cmax 峰浓度Co-investigator 合作研究者Comparison 对照Compliance 依从性Composite variable 复合变量Computer-assisted trial design， CATD 计算机辅助试验设计Confidence interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization， CRO 合同研究组织Contract/ agreement 协议／合同Control group 对照组Coordinating committee 协调委员会Crea 肌酐CRF（case report form）病例报告表Crossover design 交叉设计Cross-over study 交叉研究Css 稳浓度Cure 痊愈Data management 数据管理Database 建立数据库Descriptive statistical analysis 描述性统计分析DF 波动系统Dichotomies 二分类Diviation 偏差Documentation 记录／文件Dose-reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲Drop out 脱落DSC 差示扫描热量计Effectiveness 疗效Electronic data capture， EDC 电子数据采集系统Electronic data processing， EDP 电子数据处理系统Emergency envelope 应急信件End point 终点Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件Ethics committee 伦理委员会Excellent 显效Exclusion criteria 排除标准Factorial design 析因设计Failure 无效，失败Final point 终点Fixed-dose procedure 固定剂量法Forced titration 强制滴定Full analysis set 全分析集GC－FTIR 气相色谱－傅利叶红外联用GC－MS 气相色谱－质谱联用Generic drug 通用名药Global assessment variable 全局评价变量GLU 血糖Good clinical practice， GCP 药物临床试验质量管理规范Good manufacture practice， GMP 药品生产质量管理规范Good non-clinical laboratory practice， GLP 药物非临床研究质量管理规范Group sequential design 成组序贯设计Health economic evaluation， HEV 健康经济学评价Hypothesis test 假设检验Hypothesis testing 假设检验International Conference of Harmonization， ICH 人用药品注册技术要求国际技术协调会，国际协调会议Improvement 好转Inclusion criteria 入选标准Independent ethics committee， IEC 独立伦理委员会Information consent form， ICF 知情同意书Information gathering 信息收集Informed consent， IC 知情同意Initial meeting 启动会议Inspection 视察／检查Institution inspection 机构检查Institution review board， IBR 机构审查委员会Intention to treat 意向治疗（——临床领域）Intention-to –treat， ITT 意向性分析（－统计学）Interactive voice response system， IVRS 互动式语音应答系统Interim analysis 期中分析Investigator 研究者Investigator's brochure， IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward， LOCF 最接近一次观察的结转LC－MS 液相色谱－质谱联用LD50 板数致死剂量Logic check 逻辑检查LOQ （Limit of Quantitation）定量限LOCF， Last observation carry forward 最近一次观察的结转Lost of follow up 失访Marketing approval/ authorization 上市许可证Matched pair 匹配配对Missing value 缺失值Mixed effect model 混合效应模式Monitor 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS－MS 质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial 多中心试验Multi-center trial 多中心试验New chemical entity， NCE 新化学实体New drug application， NDA 新药申请NMR 核磁共振谱Non-clinical study 非临床研究Non-inferiority 非劣效性Non-parametric statistics 非参数统计方法Obedience 依从性ODR 旋光光谱Open-blinding 非盲Open-label 非盲Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标Outlier 离群值Parallel group design 平行组设计Parameter estimation 参数估计Parametric statistics 参数统计方法Patient file 病人档案Patient history 病历Per protocol，PP 符合方案集Placebo 安慰剂Placebo control 安慰剂对照Polytomies 多分类Power 检验效能Precision 精密度Preclinical study 临床前研究Primary endpoint 主要终点Primary variable 主要变量Principal investigator 主要研究者Principle investigator，PI 主要研究者Product license，PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit，QAU 质量保证部门Quality assurance，QA 质量保证Quality control，QC 质量控制Query list，query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities，RA 监督管理部门Replication 可重复RSD 日内和日间相对标准差Run in 准备期Safety evaluation 安全性评价Safety set 安全性评价的数据集Sample size 样本含量Sample size 样本量，样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Serious adverse event，SAE 严重不良事件Serious adverse reaction，SAR 严重不良反应Seriousness 严重性Severity 严重程度Significant level 检验水准Simple randomization 简单随机Single blinding 单盲Single-blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data verification，SDV 原始数据核准Source data，SD 原始数据Source document，SD 原始文件Specificity 特异性Sponsor 申办者Sponsor-investigator 申办研究者Standard curve 标准曲线Standard operating procedure，SOP 标准操作规程Statistic 统计量Statistical analysis plan 统计分析计划Statistical analysis plan 统计参数计划书Statistical analysis plan，SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject 受试者Subject diary 受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code，SIC 受试者识别代码Subject recruitment 受试者招募Subject screening log 受试者筛选表Superiority 检验Survival analysis 生存分析SXRD 单晶X－射线衍射System audit 系统稽查T1/2 消除半衰期Target variable 目标变量T－BIL 总胆红素T－CHO 总胆固醇TG 热重分析TLC、HPLC 制备色谱Tmax 峰时间TP 总蛋白Transformation 变量变换Treatment group 试验组Trial error 试验误差Trial master file 试验总档案Trial objective 试验目的Trial site 试验场所Triple blinding 三盲Two one-side test 双单侧检验Unblinding 揭盲Unblinding 破盲Unexpected adverse event，UAE 预料外不良事件UV－VIS 紫外－可见吸收光谱Variability 变异Variable 变量Visual analogy scale 直观类比打分法Visual check 人工检查Vulnerable subject 弱势受试者Wash-out 清洗期Washout period 洗脱期Well-being 福利，健康1．临床试验（Clinical Trial）：指任何在人体（病人或健康志愿者身上）进行药品的系统性研究，以证实或揭示研究药品的作用、不良反应及／或试验用药品的吸收、分布、代谢和排泄，目的是确定研究药品的疗效与安全性。
医药行业专业英语词汇词典
FDA和EDQM术语:CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROVAL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFITS：受益RISKS：受害DRUG PRODUCT：药物产品DRUG SUBSTANCE：原料药ESTABLISHED NAME：确定的名称GENERIC NAME：非专利名称PROPRIETARY NAME：专有名称；INNINTERNATIONAL NONPROPRIETARY NAME：国际非专有名称ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIVAL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典主要指USP、 NF．USPTHE UNITED STATES PHARMACOPEIA：美国药典NFNATIONAL FORMULARY：美国国家处方集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门指FDAIDENTITY：真伪；鉴别；特性STRENGTH：规格；规格含量每一剂量单位所含有效成分的量LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准NDA提供REGULATORY METHODOLOGY：质量管理方法REGULATORY METHODS VALIDATION：管理用分析方法的验证COS/CEP 欧洲药典符合性认证ICHInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类..质量技术要求文件以Q开头;再以a;b;c;d代表小项:Q1:药品的稳定性Q2:方法学Q3:杂质Q4:药典Q5:生物技术产品质量Q6:标准规格Q7:GMPQ7a:原料药的优良制造规范指南药物活性成分的GMP.GMP英语PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme; PIC/S制药检查草案; 药品检查协会PIC/S ;也有人称PIC/S为医药审查会议/合作计划PIC/SPIC的权威翻译：药品生产检查相互承认公约APIActive Pharmaceutical Ingredient 原料药又称：活性药物组分AirLock 气闸 Authorized Person 授权人 Batch/Lot 批次Batch Number/Lot-Number 批号；Batch Numbering System 批次编码系统；Batch Records 批记录；Bulk Product 待包装品；Calibration 校正；Clean area 洁净区；ConsignmentDelivery托销药品..FDAFOOD AND DRUG ADMINISTRATION：美国食品药品管理局INDINVESTIGATIONAL NEW DRUG：临床研究申请指申报阶段;相对于NDA而言；研究中的新药指新药开发阶段;相对于新药而言;即临床前研究结束NDANEW DRUG APPLICATION：新药申请ANDAABBREVIATED NEW DRUG APPLICATION：简化新药申请TREATMENT IND：研究中的新药用于治疗ABBREVIATEDNEWDRUG：简化申请的新药DMFDRUG MASTER FILE：药物主文件持有者为谨慎起见而准备的保密资料;可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品..只有在DMF持有者或授权代表以授权书的形式授权给FDA;FDA在审查IND、NDA、ANDA时才能参考其内容HOLDER：DMF持有者CFRCODE OF FEDERAL REGULATION：美国联邦法规PANEL：专家小组BATCH PRODUCTION：批量生产；分批生产BATCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：知情同意患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验PRESCRIPTION DRUG：处方药OTC DRUGOVER—THE—COUNTER DRUG：非处方药GMP文件常见缩写ABPI Association of the British Pharmaceutical Industry 英国制药工业协会ADR Adverse Drug Reaction 药品不良反应AE Adverse Event 不良事件;不良反应AIM Active Ingredient Manufacturer 原料药制造商ANDA Abbreviated New Drug Application 简化新药申请ANOVA Analysis of Variance 方差分析ASM: Active Substance Manufacturer原料药制造商ATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION CDECentre for Pharmaceutical Administration CPA CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal Products CRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug Registration Branch DR; Product Evaluation & Registration Division; CPAEDQM European Directorate for the Quality of Medicines 欧洲联盟药品质量指导委员会EEA 欧洲经济地区EGMA European Generics Medicine AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA European Agency for the Evaluation of Medicinal Products 欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug Administrationfinal evaluation report FERfree sale certificates FSCsGCP Good Clinical PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority HSAHSA’s Medicines Advisory Committee MACIB Investigators BrochureICH International Conference for Harmonisation IDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary Name International Conference on Harmonisation ICH IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare JapanMR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs Mutual Recognition Agreements 互相认证同意MRFG Mutual Recognition Facilitation Group MRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities NCEsnew drug applications NDAsNSAID Non Steroidal Anti Inflammatory Drug NTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great Britain Ph Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP STANDARD OPERATION PROCEDURE 标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristicsSPCTherapeutic Goods Administration TGAUSP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products CommitteeA．A．A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会美国ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity Image 企业识别形象CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局美国GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction File 生产记录用表格OTC Over the Counter Drug 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典专业英语词汇词素词根1. haplo;mono;uni ：单;一;独haploid 单倍体monoxide一氧化碳monoatomic单原子的2. bi;di;dipl;twi;du :：二;双;两;偶 biocolor 双色;dichromatic 双色的;diplobacillus 双杆菌 dikaryon 双核体twin ：孪生 dual 双重的3. tri :三;丙 triangle三角 triacylglycerol三酰甘油 tricarboxylic acid cycle 三羧酸循环4. quadri;quadru;quart;tetr;tetra：四 quadrilateral四边的 quadrivalent 四价的 quadruped四足动物tetrode四极管 tetracycline四环素5. pent;penta;quique五pentose戊糖pentagon五角形pentane戊烷quintuple 五倍的 pentose戊糖 pentomer五邻粒6. hex;hexa;sex 六 hexose已糖 hexapod六足动物hexapoda昆虫纲 hexamer 六聚体7. hepta;sept 七 heptane 庚烷 heptose 庚糖 heptoglobin七珠蛋白8. oct八 octpus 章鱼 octagon八角形 octane 辛烷 octase 辛糖9. enne;nona九 nonapeptide 九肽 enneahedron 九面体10. deca;deka 十 :decapod 十足目动物 decahedron 十面体 decagram 十克11. hecto; 百 hectometer百米 hectoliter百升 hectowatt 百瓦12. kilo;千 kilodalton KD 千道尔顿 kilobase 千碱基 kiloelectron volt 千电子伏特13. deci;十分之一;分 decimeter 分米decigram 十分之一克14. centi;百分之一15. milli;千分之一;毫millimole 毫摩尔milliliter 毫升16. micro;百万分之一;微;微小;微量microgram微克 microogranism微生物microecology微生态学micropipet微量移液器17. nano十亿分之一;毫微;纳nanosecond十亿分之一秒nanometer纳米18. demi;hemi;semi半 demibariel 半桶 hemicerebrum 大脑半球semiopaque 半透明 semi-allel半等位基因 semi-conductor半导体19. holo 全;整体;完全 holoenzyme 全酶holoprotein全蛋白 holocrine全质分泌20. mega巨大;兆;百万 megaspore大孢子;megabasse兆碱基megakaryocyte巨核细胞megavolt兆伏 megalopolitan特大城市21. macro 大;巨大;多macrophage巨噬细胞macrogamete大配子macroelement 常量元素 macromolecular大分子22. poly;multi;mult 多;复合polyacrylate聚丙烯酸酯 polymerase 聚合酶multichain多链的multinucleate 多核的 multicistronic mRNA多顺反子mRNA multicopy多拷贝1 chrom颜色chromophore生色团 chromosome染色体 chromatography色谱法2 melan;melano;nigr 黑melanoma黑素瘤melanin黑色素melanophore黑色素细胞3 xantho;flavo;fla;flavi;lute黄xanthophyl叶黄素 xanthous黄色的;黄色人种xathine黄嘌呤 flavin黄素flavone黄酮 letein黄体素;叶黄素flavin adenine dinucleotideFAD黄素腺嘌呤二核苷酸4 erythro; rub; rubrm; ruf;红erythrocyte红细胞erythromycin红霉素erythropoitinEPO促红细胞生成素5 chloro;chlor绿;氯chlorophyll叶绿素 chloride氯化物chloramphenicol氯霉素6 cyan;cyano 蓝;青紫色;氰cyanophyceae 蓝藻纲 cyanobacteria蓝细菌cyanide氰化物7 aur;glid;chrys金色aureomycin金霉素chrysose 金藻淀粉 chrysanthemum菊花 glidstone 金沙石glid 镀金8 leu;leuco;leuk;leuko;blan;alb无色;白色leucine亮氨酸leukaemia=leucosis白血病bleaching powder漂白粉albomycin白霉素四表示方位和程度的词素1 endo;ento;内;在内endocrine内分泌endocytosis胞吞作用 endogamy近亲繁殖 endolysin内溶素entoderm内胚层2 ec; ect; exc; extra 外;外面;表面ectoblast外胚层 ectoparasite 外寄生生物 extract 抽取;浸出3 meso 中;中间mesosphere 中圈;中层 mesoplast 中胚层质4 intra;intro;inter 在内;向内intra-allelic interaction 等位基因内相互作用 intracellular细胞内的interurban城市之间5 centri;centro;medi;mid 中心;中央;中间centrifuge离心 centriole 中心粒centrosome 中心体 centrogeng着丝基因6 epi;peri 上;外;旁epidermal growth factorEGF: 表皮生长因子 epibranchial上鳃的perilune 近月点7 sub;suc;suf;sug 下;低;小suborder 亚目 submucosa粘膜下层subclone亚克隆 subcellular亚细胞subsection小节;分部8 super;supra 上;高;超superconductor超导体superfluid 超流体superoxide 超氧化物supramolecular超分子的9 hyper 超过;过多hypersensitive 过敏的hyperelastic 超弹性的hypertension 高血压hyperploid 超倍体10 hypo下;低;次hypoglycaemia 低血糖 hypotension低血压hypophysis脑下垂体11 iso 等;相同;同iso-osmotic等渗的isopod等足目动物 isotope同位素12 oligo;olig少;低;寡;狭oligohaline 狭盐性 oligogene寡基因 oligomer寡聚体 oligophagous寡食性oligarchy寡头13 eury 多;宽;广eurythermal 广温的 euryhaline广盐性eurytopic species广幅种14 ultr 超ultra-acoustics 超声学ultra-structure超微结构ultroviolet紫外线15 infra 下;低;远infralittoral 潮下带;远岸的infrahuman类人生物infrared红外线的infrastructure基础结构;基本结构五表示动物不同器官和组织的词素1 cephal;capit;cran 头;头颅2 cyte 细胞3 carn;my;mya;myo;肉;肌肉4 haem;haemat;hem;aem;sangul 血5 soma;corp 体;身体6 some;plast 体;颗粒7 hepa;hepat 肝 heparin 肝素 hepatopancreas肝胰腺 hepatocyte 肝细胞hepatoma肝癌8 ren;nephr 肾adrnal肾上腺的 nephridia肾管 nephron肾单位9 card;cord 心 cardiotoxin 心脏毒素 cardiovascular center 心血管中枢electrocardiogram心电图 concord一致;和谐10 ophthalm;ocell;ocul 眼ophthalmology眼科学ophthalmia眼炎ophthalmologist眼科专家11 branchi 鳃 filibranch丝鳃 lamellibrnch瓣鳃 sencondary branchium次生鳃12 brac ;brachi 腕;手臂 brachiolaria 短腕幼虫brachionectin臂粘连蛋白bracelet手镯13 dent;odont 牙齿 dentin牙质 odontphora 齿舌 odontoblast成牙质细胞14 plum羽 plumatus 羽状的 plumule绒毛 plumage 鸟的羽毛15 foli;foil 叶 follicle滤泡 foiling叶形 foliage 叶子 foliose 多叶的药名常用词首ace- 乙酰基acet- 醋；醋酸；乙酸acetamido- 乙酰胺基acetenyl- 乙炔基acetoxy- 醋酸基；乙酰氧基acetyl- 乙酰基aetio- 初allo- 别allyl- 烯丙基；CH2=CH-CH2-amido- 酰胺基amino- 氨基amyl- ①淀粉②戊基amylo- 淀粉andr- 雄andro- 雄anilino- 苯胺基anisoyl- 茴香酰；甲氧苯酰anti- 抗apo- 阿朴；去水aryl- 芳香基aspartyl- 门冬氨酰auri- 金基；三价金基aza- 氮杂azido- 叠氮azo- 偶氮basi- 碱baso- 碱benxoyl- 苯酰；苯甲酰benzyl- 苄基；苯甲酰bi- 二；双；重biphenyl- 联苯基biphenylyl- 联苯基bis- 双；二bor- 硼boro- 硼bromo- 溴butenyl- 丁烯基有1、2、3位三种butoxyl- 丁氧基butyl- 丁基butyryl- 丁酰caprinoyl- 癸酰caproyl- 己酰calc- 钙calci- 钙calco- 钙capryl- 癸酰capryloyl- 辛酰caprylyl- 辛酰cef- 头孢头孢菌素族抗生素词首chlor- ①氯②绿chloro- ①氯②绿ciclo- 环cis- 顺clo- 氯crypto- 隐cycl- 环cyclo- 环de- 去；脱dec- 十；癸deca- 十；癸dehydro- 去氢；去水demethoxy- 去甲氧基demethyl- 去甲基deoxy- 去氧des- 去；脱desmethyl- 去甲基desoxy- 去氧dex- 右旋dextro- 右旋di- 二diamino- 二氨基diazo- 重氮dihydro- 二氢；双氢endo- 桥epi- 表；差向epoxy- 环氧erythro- 红；赤estr- 雌ethinyl- 乙炔基ethoxyl- 乙氧基ethyl- 乙基etio- 初eu- 优fluor- ①氟②荧光fluoro- ①氟②荧光formyl- 甲酰基guanyl- 脒基hepta- 七；庚hetero- 杂hexa- 六；己homo- 高比原化合物多一个-CH2-hypo- 次io- 碘indo- 碘iso- 异keto- 酮laevo- 左旋leuco- 白levo- 左旋mercapto- 巯基meso- ①不旋；内消旋②中间③中位蒽环的9、10位meta- ①间有机系统用名②偏无机酸用methoxy- 甲氧基methyl- 甲基mono- 一；单neo- 新nitro- 硝基nitroso- 亚硝基nona- 九；壬nor- 去甲；降；正nov- 新novo- 新oct- 八；辛octa- 八；辛octo- 八；辛ortho- ①邻位②正③原oxalo- 草oxo- 氧代oxy- ①氧②羟基误称;但常用para- ①对位②副俗名penta- 五；戊per- ①高②过phen- 苯pheno- 苯phenoxy- 苯氧基phenyl- 苯基phospho- 磷；磷酸phosphor- 磷；磷酸phosphoro- 磷；磷酸phyllo- 叶poly- 多；聚propyl- 丙基proto- 原pseudo- 假；伪；拟ribosyl- 核糖基sec- ①另指CH3CH2CHCH3-型烃基②semi- 半silico- 硅strept- 链strepto- 链sulf- 硫sulfa- 磺胺磺胺类药物词头sulfo- ①硫代②磺基sulph- 硫代sulpho- ①硫代②磺基tert- ①特指CH3…CCH32-型烃基②叔tetra- 四thio- 硫trans- 反式；转tri- 三undeca- 十一valyl- 缬氨酰基vinyl- 乙烯基xantho- 黄色药名常用词尾-al 醛-aldehyde 醛-amide 酰胺-amidine 脒-amine 胺-ane 烷-ase 酶-ate ①盐②酯-azide 叠氮；-N3-caine 卡因局部麻醉药词尾-carbonyl 羰基-carboxamide 甲酰胺-carboxylic acid 羧酸-cidin 杀……菌素-cillin 青霉素；西林青霉素族抗生素词尾-cycline 四环素四环素族抗生素词尾-diol ①二醇②二酚-dione 二酮-disulfide 二硫化物-ene 烯-enol 烯醇-ester 酯-flavine 黄素-form 仿俗名词尾-genin 甙元旧称配基-hydrin 醇-ine 碱；素生物碱词尾-lactone 内酯-lysin 溶素俗名词尾-micin 霉素抗生素词尾-mycetin 霉素；菌素抗生素词尾-mycin 霉素抗生素词尾-nitrile 腈-ol ①醇②酚-olol 心安心安类药物词尾-one 酮-ose 糖-oside 糖甙-oxide 氧；氧化物-oyl 酰-quine 奎俗名尾词-sporin 孢菌素抗生素词尾-sullide 硫化物-sulfone 砜-sulfoxide 亚砜-thioic acid 硫代酸-thione 硫酮-thione 硫酮-toxin 毒-triol 三醇-tropin 托品俗名尾词-urea 脲-xanthin 黄质-yl 基一价基-yne 炔常用分析化学词汇C to E玻璃漏斗 Glass funnel long stem试管 test tube test tube brush test tube holder test tube rack 蒸发皿 evaporating dish small烧杯 beaker锥形瓶 Erlenmeyer量筒 grad cylinder洗瓶 plastic wash bottle勺皿 casserole ;smallstoppered flask分液漏斗 separalory funnelwater bath/oil bathstrring barmagnetic stirrer冷凝器 condenserBallast bottle圆颈烧瓶 Round-buttom flask试剂瓶 reagent bottles托盘天平 platform balance 台秤0.1g 托盘pan 指针刻度表pointer and scale crossbeams and sliding weights 游码分析天平 two-pan/single-pan analytical balance 滴定管 burette glass beadbasic nozzle移液管 pipette 胖肚 elongated glass bulb洗耳球 rubber suction bulb玻棒 glass rod玻璃活塞 stopcock容量瓶 pyknowmeter flasks比重瓶 one-markvolumetric flasks胖肚吸管 one-mark pipette刻度吸管 graduated pipettes实验仪器清单1、柜子中四、抽屉中：锥形瓶conical flask 250ml×4 药匙medicine spoon×1Erlenmeyer flask 100 ml×3 滴管drip tube;dropper×2烧杯beaker 500 ml×1 玻棒Glass stic×2250 ml×3 木试管夹test tube clamp;test tube holder×1100 ml×3 胖肚吸管straws 25 ml×150 ml×2 10 ml×1容量瓶volumetric flask 100 ml×2 乳钵morta×150 ml×4 洗耳球ear wadhing bulb碘量瓶 iodin numoe flask;iodineflask 500 ml×3试剂瓶 reagent bottle 无色×2棕色×2 配洗液：量筒cylinder 100 ml×1 K2Cr2O72g+5ml水→65mlH2SO4graduated cylinder10ml×1 边加边搅拌stir..二、台面上仪器：一般仪器的洗涤wash铁支架siderocradle+蝴蝶架白瓷板White Porcelain Board 一清点仪器to count;to make an inventory酸式滴定管Acid burette 25 ml×1 配洗液 Lotion碱式滴定管Alkali burette25 ml×1 一般仪器的洗涤三、公用柜中：二滴定管buret;burette直型冷凝器rectocondensor×1 容量瓶volumetric flask漏斗架 funnel stand ×2 移液管pipe水浴锅water bath kettle ×1温度计Thermometer;hygrometer;hydroscope ×1电炉electric furnace;electric hot plate;electric stove 四人一个分析化学：analytical chemistry定性分析：qualitative analysis定量分析：quantitative analysis物理分析：physical analysis物理化学分析：physico-chemical analysis仪器分析法：instrumental analysis流动注射分析法：flow injection analysis；FIA顺序注射分析法：sequentical injection analysis;SIA化学计量学：chemometrics绝对误差：absolute error相对误差：relative error系统误差：systematic error可定误差：determinate error随机误差：accidental error不可定误差：indeterminate error准确度：accuracy精确度：precision偏差：debiation;d平均偏差：average debiation相对平均偏差：relative average debiation标准偏差标准差：standerd deviation;S相对平均偏差：relatibe standard deviation;RSD变异系数：coefficient of variation误差传递：propagation of error有效数字：significant figure置信水平：confidence level显着性水平：level of significance合并标准偏差组合标准差：pooled standard debiation 舍弃商：rejection quotient ;Q滴定分析法：titrametric analysis滴定：titration容量分析法:volumetric analysis化学计量点：stoichiometric point等当点：equivalent point电荷平衡：charge balance电荷平衡式：charge balance equation质量平衡：mass balance物料平衡：material balance质量平衡式：mass balance equation酸碱滴定法：acid-base titrations质子自递反应：autoprotolysis reaction质子自递常数：autoprotolysis constant质子条件式:proton balance equation酸碱指示剂：acid-base indicator指示剂常数：indicator constant变色范围：colour change interval混合指示剂：mixed indicator双指示剂滴定法：double indicator titration 非水滴定法：nonaqueous titrations质子溶剂：protonic solvent酸性溶剂：acid solvent碱性溶剂：basic solvent两性溶剂:amphototeric solvent无质子溶剂：aprotic solvent均化效应：differentiating effect区分性溶剂：differentiating solvent离子化：ionization离解：dissociation结晶紫：crystal violet萘酚苯甲醇: α-naphthalphenol benzyl alcohol奎哪啶红：quinadinered百里酚蓝：thymol blue偶氮紫：azo violet溴酚蓝：bromophenol blue配位滴定法：compleximetry乙二胺四乙酸：ethylenediamine tetraacetic acid;EDTA 螯合物：chelate compound金属指示剂：metal lochrome indcator氧化还原滴定法：oxidation-reduction titration碘量法：iodimetry溴量法：bromimetry溴量法：bromine method铈量法：cerimetry高锰酸钾法：potassium permanganate method条件电位：conditional potential溴酸钾法：potassium bromate method硫酸铈法：cerium sulphate method偏高碘酸：metaperiodic acid高碘酸盐：periodate亚硝酸钠法：sodium nitrite method重氮化反应：diazotization reaction重氮化滴定法：diazotization titration亚硝基化反应：nitrozation reaction亚硝基化滴定法：nitrozation titration外指示剂：external indicator外指示剂：outside indicator重铬酸钾法：potassium dichromate method沉淀滴定法：precipitation titration容量滴定法：volumetric precipitation method 银量法：argentometric method重量分析法：gravimetric analysis挥发法：volatilization method引湿水湿存水：water of hydroscopicity包埋藏水：occluded water吸入水：water of imbibition结晶水：water of crystallization组成水：water of composition液-液萃取法：liquid-liquid extration溶剂萃取法：solvent extration反萃取：counter extraction分配系数：partition coefficient分配比：distribution ratio离子对离子缔合物：ion pair沉淀形式：precipitation forms称量形式：weighing forms物理分析：physical analysis物理化学分析：physicochemical analysis 仪器分析：instrumental analysis电化学分析：electrochemical analysis 电解法：electrolytic analysis method 电重量法：electtogravimetry库仑法：coulometry库仑滴定法：coulometric titration电导法：conductometry电导分析法：conductometric analysis电导滴定法：conductometric titration 电位法：potentiometry直接电位法：dirext potentiometry电位滴定法：potentiometric titration 伏安法：voltammetry极谱法：polarography溶出法：stripping method电流滴定法：amperometric titration化学双电层：chemical double layer相界电位：phase boundary potential金属电极电位：electrode potential化学电池：chemical cell液接界面：liquid junction boundary原电池：galvanic cell电解池：electrolytic cell负极：cathrode正极：anode电池电动势：eletromotive force指示电极：indicator electrode参比电极：reference electroade标准氢电极：standard hydrogen electrode一级参比电极：primary reference electrode饱和甘汞电极：standard calomel electrode银－氯化银电极：silver silver-chloride electrode 液接界面：liquid junction boundary不对称电位：asymmetry potential表观PH值：apparent PH复合PH电极：combination PH electrode离子选择电极：ion selective electrode敏感器：sensor晶体电极:crystalline electrodes均相膜电极：homogeneous membrance electrodes非均相膜电极：heterog eneous membrance electrodes非晶体电极：non- crystalline electrodes刚性基质电极：rigid matrix electrode流流体载动电极：electrode with a mobile carrier气敏电极：gas sensing electrodes酶电极：enzyme electrodes金属氧化物半导体场效应晶体管：MOSFET离子选择场效应管：ISFET总离子强度调节缓冲剂：total ion strength adjustment buffer;TISAB永停滴定法：dead-stop titration双电流滴定法双安培滴定法：double amperometric titration普朗克常数：Plank constant电磁波谱：electromagnetic spectrum光谱：spectrum光谱分析法：spectroscopic analysis原子发射光谱法：atomic emission spectroscopy质量谱：mass spectrum质谱法：mass spectroscopy;MS紫外－可见分光光度法：ultraviolet and visible spectrophotometry;UV-vis 肩峰：shoulder peak末端吸收：end absorbtion生色团：chromophore助色团：auxochrome红移：red shift长移：bathochromic shift短移：hypsochromic shift蓝紫移：blue shift增色效应浓色效应：hyperchromic effect减色效应淡色效应：hypochromic effect强带：strong band弱带：weak band吸收带：absorption band透光率：transmitance;T吸光度：absorbance谱带宽度：band width杂散光：stray light噪声：noise暗噪声：dark noise散粒噪声：signal shot noise闪耀光栅：blazed grating全息光栅：holographic graaing光二极管阵列检测器：photodiode array detector 偏最小二乘法：partial least squares method ;PLS褶合光谱法：convolution spectrometry褶合变换：convolution transform;CT离散小波变换：wavelet transform;WT多尺度细化分析：multiscale analysis供电子取代基：electron donating group吸电子取代基：electron with-drawing group 荧光：fluorescence荧光分析法：fluorometryX-射线荧光分析法：X-ray fulorometry原子荧光分析法：atomic fluorometry分子荧光分析法：molecular fluorometry振动弛豫：vibrational relexation内转换：internal conversion外转换：external conversion体系间跨越：intersystem crossing激发光谱：excitation spectrum荧光光谱：fluorescence spectrum斯托克斯位移：Stokes shift荧光寿命：fluorescence life time荧光效率：fluorescence efficiency荧光量子产率：fluorescence quantum yield 荧光熄灭法：fluorescence quemching method散射光：scattering light瑞利光：Reyleith scanttering light拉曼光：Raman scattering light红外线：infrared ray;IR中红外吸收光谱：mid-infrared absorption spectrum;Mid-IR 远红外光谱：Far-IR微波谱：microwave spectrum;MV红外吸收光谱法：infrared spectroscopy红外分光光度法：infrared spectrophotometry振动形式：mode of vibration伸缩振动：stretching vibration对称伸缩振动：symmetrical stretching vibration不对称伸缩振动：asymmetrical stretching vibration弯曲振动：bending vibration变形振动：formation vibration面内弯曲振动:in-plane bending vibration;β剪式振动：scissoring vibration;δ面内摇摆振动：rocking vibration;ρ核磁共振：nuclear magnetic resonance;NMR核磁共振波谱：NMR spectrum核磁共振波谱法：NMR spectroscopy扫场：swept field扫频：seept frequency连续波核磁共振：continuous wave NMR;CW NMRFourier变换NMR：PFT-NMR;FT-NMR二维核磁共振谱：2D-NMR质子核磁共振谱：proton magnetic resonance spectrum;PMR 氢谱：1H-NMR碳－13核磁共振谱：13C-NMR spectrum;13CNMR自旋角动量：spin angular momentum磁旋比：magnetogyric ratio磁量子数：magnetic quantum number;m进动：precession弛豫历程：relaxation mechanism局部抗磁屏蔽：local diamagnetic shielding屏蔽常数：shielding constant化学位移：chemical shift国际纯粹与应用化学协会：IUPAC磁各向异性：magnetic anisotropy远程屏蔽效应：long range shielding effect结面：nodal plane自旋－自旋偶合：spin-spin coupling自旋－自旋分裂：spin=spin splitting单峰：singlet;s双峰：doublet;d三重峰：triplet;t四重峰：quartet五重峰：quintet六重峰：sextet偕偶：geminal coupling邻偶：vicinal coupling远程偶合：long range coupling磁等价：magnetic eqivalence自旋系统：spin system一级光谱：first order spectrum二级光谱二级图谱：second order spectrumC-H光谱：C-H correlated spectroscopy;C-H COSY质谱分析法：mass spectrometry质谱：mass spectrum;MS棒图：bar graph选择离子检测：selected ion monitoring ;SIM直接进样：direct probe inlet ;DPI接口：interface气相色谱－质谱联用：gas chromatography-mass spectrometry;GC-MS高效液相色谱－质谱联用：high performance liquid chromatography-mass spectrometry;HPLC-MS电子轰击离子源：electron impact source;EI离子峰：quasi-molecular ions化学离子源：chemical ionization source;CI场电离：field ionization;FI场解析：field desorptiion;FD快速原子轰击离子源：fast stom bombardment ;FAB质量分析器：mass analyzer磁质谱仪：magnetic-sector mass spectrometer四极杆质谱仪四极质谱仪：quadrupole mass spectrometer 原子质量单位:amu离子丰度：ion abundance相对丰度相对强度：relative avundance基峰：base peak质量范围：mass range分辨率：resolution灵敏度：sensitivity信噪比：S/N分子离子：molecular ion碎片离子：fragment ion同位素离子：isotopic ion亚稳离子：metastable ion亚稳峰：metastable peak母离子：paren ion子离子：daughter含奇数个电子的离子：odd electron含偶数个电子的离子：even eletron;EE均裂：homolytic cleavage异裂非均裂：heterolytic cleavage半均裂：hemi-homolysis cleavage重排：rearragement分子量：MWα－裂解：α-cleavage固定相：stationary phase化学键合相：chemically bonde phase封尾、封顶、遮盖：end capping手性固定相：chiral stationary phase;CSP恒组成溶剂洗脱：isocraic elution梯度洗脱：gradient elution紫外检测器：ultraviolet detector;UVD荧光检测器：fluorophotomeric detector;FD电化学检测器：ECD示差折光检测器：RID光电二极管检测器：photodiode array detector ;DAD 三维光谱－波谱图：3D-spectrochromatogram蒸发光散射检测器：evaporative light scattering detector;ELSD 释药系统drug delivery system;DDS中国药典Chinese Pharmacopoeia;ChP美国药典The United States Pharmacopoeia;USP美国国家处方集The National Formulary;NF英国药典British Pharmacopoeia;BP欧洲药典European Pharmacopoeia;Ph.Eup国际药典The International Pharmacopoeia;Ph.Int良好药品实验研究规范Good Laboratory Practice;GLP良好药品生产规范Good Manufacture Practice;GMP良好药品供应规范Good Supply Practice;GSP良好药品临床试验规范Good Clinical Practice;GCP分析质量管理Analytical Quality Control;AQC边缘效应 edge effect斑点定位法 localization of spot放射自显影法 autoradiography原位定量 in situ quantitation生物自显影法 bioautography归一法 normalization method内标法 internal standard method外标法 external standard method叠加法 addition method普适校准曲线、函数 calibration function or curve function谱带扩展加宽 band broadening分离作用的校准函数或校准曲线 universal calibration function or curve of separation加宽校正 broadening correction加宽校正因子 broadening correction factor溶剂强度参数ε0;solvent strength parameter洗脱序列 eluotropic series洗脱淋洗 elution等度洗脱 gradient elution梯度洗脱 gradient elution再循环洗脱 recycling elution线性溶剂强度洗脱 linear solvent strength gradient程序溶剂 programmed solvent程序压力 programmed pressure程序流速 programmed flow展开 development上行展开 ascending development下行展开 descending development双向展开 two dimensional development环形展开 circular development离心展开 centrifugal development向心展开 centripetal development径向展开 radial development多次展开 multiple development分步展开 stepwise development连续展开 continuous development梯度展开 gradient development匀浆填充 slurry packing停流进样 stop-flow injection阀进样 valve injection柱上富集 on-column enrichment流出液 eluate柱上检测 on-column detection柱寿命 column life柱流失 column bleeding显谱 visualization活化 activation反冲 back flushing脱气 degassing沟流 channeling过载 overloading分析化学方面的词汇abatement 1:减少 2：消除；ablution 1:清洗 2：洗净液；。
超实用，手把手教你在ClinicalTrials.gov临床注册
超实用，手把手教你在临床注册2019-09-20 12:22目前，很多专家和学者都热衷于临床试验研究，出于伦理和科学的研究，一项临床试验在实施前需要在公开数据库上进行注册，并跟踪和报告试验结果。
临床试验注册制度已成为当前临床试验发展的主流趋势。
然而，很多研究者对于如何完成临床试验注册并不了解，本文以美国为例，和大家分享下如何进行临床试验注册。
为什么要进行临床注册？1）开展临床试验注册的目的主要是出于伦理和科学的要求，试验注册可确保追踪到所有试验的结果，通过深入了解试验的过程和结果，可有助于降低偏倚风险。
2）开放获取正在进行或已完成的试验的信息既符合保护受试者的伦理责任，也进一步提升工作对临床研究的信任。
3）对于受试对象而言，他们也希望对医学领域的贡献用来改善人群的卫生保健质量。
什么样的临床研究需要注册？所有在人体中和采用取自人体的标本进行的研究，包括各种干预措施的疗效和安全性的有对照或无对照试验（如随机对照试验、病例-对照研究、队列研究及非对照研究）、预后研究、病因学研究、和包括各种诊断技术、试剂、设备的诊断性试验，均需注册并公告。
临床试验注册平台简介目前，国际上临床试验注册平台有很多，包括：世界卫生组织国际临床试验注册平台（WHO ICTRP，有多个一级注册机构），英国国立研究注册库（BNNR），澳大利亚临床试验注册库（ACTR），英国当前对照试验注册库（CCT），美国临床试验注册库（);中国也有自己的临床试验注册中心（ChiCTR)。
为了避免利益冲突，提高公众的信任度，临床试验注册库的创建和管理应符合一定的要求。
国际医学杂志编辑委员会（ICMJE）对临床试验注册库提出了一定的标准，详见图1。
由于注册流程简便，符合ICMJE标准，是当前最具国际影响力的临床试验注册机构之一，应用最为广泛。
图1. 国际临床试验注册机构/平台及ICMJE标准ClinicalTrials. gov主要优势有以下几点：1）注册流程简洁快速2）信息单元严谨巧妙3）操作界面清晰友好4）开放的临床试验资料库5）良好的内在质控系统ClinicalTrials. gov简介ClinicalTrials. gov于1997年由美国国家医学图书馆（NML）和美国食品与药物管理局（FDA）共同创办，内容涉及各种疾病及其症状。
ClinicalTrial
概 述—原 理
选定患有某种疾病的病人(住院病人或非住院 病人），将他们随机分为实验组和对照组，对实 验组病人施加某种预防或治疗的干预措施后，随 访并观察一段时间，比较两组病人的发病结局， 从而判断干预措施的预防或治疗效果。
概 述—核心要素
以人作为研究对象 前瞻性研究 大部分有用于比较的对照组 有干预措施并有评价干预效果的方法 着重于评价未知疗效 在某疗法成为临护标准前进行 在疗法研制早期进行
测试新药须经过一系列程序：
-#1：实验室中进行各种前期试验 -#2：若认为是安全的，则进入临床1-4期
测试
概 述—临床试验分期
临床 I 期
为人体新药试验起始期 评价安全性、决定安全剂量范围和鉴别
副反应 在健康志愿者中进行 病例数20-80例
概 述—临床试验分期
临床 II 期
评价药物疗效、监测副反应并进一步评 价安全性
1628：放血治疗发烧(Dr Van Helmont) 1747：橘子和酸橙治疗坏血病(Dr Lind) 药物试验 1909：Arsphenamine (606)(Paul Ehrlich) 1929：青霉素(Alexander Fleming) 1935：磺胺(Gerhard Domagk) 1944：链霉素(Schatz/Bugie/Waksman) 1950：建立了用于研究和评价治疗干预的方法学
临床试验应注意的问题—临床依从性
衡量依从性方法：
依从性＝ 患者已经服用的处方药 处方的药物总量
量 100％
计数患者剩余处方药量 药物水平测定方法 从治疗预期效果分析依从性 直接询问病人
临床试验应注意的问题—临床依从性
低依从性原因
临床实验英文
临床实验英文Clinical Trials: An Essential Component of Medical ResearchIntroductionClinical trials play a crucial role in advancing medical knowledge and improving patient care. They are an essential component of clinical research, providing valuable insights into the effectiveness and safety of new treatments and interventions. This article aims to highlight the importance of clinical trials in the field of medicine and shed light on their key features and processes.Importance of Clinical TrialsClinical trials serve as the gold standard for evaluating the effectiveness and safety of medical interventions. They provide scientific evidence that guides healthcare professionals in making informed decisions about patient care. By systematically studying the effects of new drugs, therapies, and medical devices, clinical trials offer a reliable way to assess their benefits, risks, and optimal dosage.Without clinical trials, medical progress would be severely limited. These trials are instrumental in the development of new treatments for various diseases and conditions, ranging from cancer and heart disease to mental health disorders and rare genetic disorders. They pave the way for innovative therapies and interventions that save lives, improve quality of life, and bring hope to patients and their families.Key Features of Clinical Trials1. Protocol Development: Clinical trials are conducted based on a detailed protocol that outlines the study's objectives, design, participant eligibility criteria, treatment plan, and data analysis methods. The protocol is carefully developed to ensure the scientific validity and ethical considerations of the study.2. Participant Recruitment and Informed Consent: Participants are recruited based on specific eligibility criteria, which may include age, gender, medical history, and disease severity. Informed consent is obtained from all participants, ensuring that they fully understand the study's purpose, procedures, potential risks, and benefits before agreeing to participate.3. Randomization and Blinding: To minimize bias, clinical trials often employ randomization, whereby participants are randomly assigned to different treatment groups. Blinding, either single or double, is also employed to reduce the influence of subjective bias during data collection and analysis.4. Data Collection and Analysis: Rigorous data collection processes and standardized outcome measures are employed to ensure the accuracy and reliability of the results. Data analysis involves statistical methods to determine the treatment's effectiveness, safety, and adverse events. These findings are usually published in scientific journals to contribute to the existing body of medical knowledge.5. Ethical Considerations: Clinical trials must adhere to strict ethical guidelines to protect participant rights, privacy, and welfare. Independent ethics committees or institutional review boards oversee the study's ethicalaspects, ensuring the well-being of participants and the scientific integrity of the trial.Phases of Clinical TrialsClinical trials typically proceed through several phases, each serving a distinct purpose in the evaluation of a new medical intervention.1. Phase 1: In this initial phase, a small group of healthy volunteers or patients is administered the experimental treatment to evaluate its safety, dosage, and adverse effects.2. Phase 2: If the treatment shows promise in Phase 1, Phase 2 involves a larger group of participants to further assess its effectiveness and side effects. This phase often involves comparing the new treatment with existing standard treatments or placebos.3. Phase 3: Phase 3 trials involve large groups of patients to confirm the treatment's effectiveness, monitor side effects, and compare it with existing treatments. These trials are pivotal in determining whether the new treatment should be approved for clinical use.4. Phase 4: Also known as post-marketing surveillance, Phase 4 trials continue to monitor the treatment's safety and effectiveness after it has been approved for clinical use. These trials may identify rare or long-term side effects that were not evident during the earlier phases.ConclusionClinical trials are the backbone of medical research, providing a systematic and reliable way to evaluate the efficacy and safety of newmedical interventions. Their importance cannot be overstated, as they contribute to medical advancements and improved patient care. Through rigorous protocols, ethical considerations, and scientific analysis, clinical trials continue to shape the future of healthcare, offering new hope and possibilities for patients worldwide.References:1. World Health Organization. (2018). Clinical Trials: The Basics. Retrieved from https://www.who.int/news-room/q-a-detail/clinical-trials-the-basics2. National Institutes of Health. (2021). . Retrieved from https:///。
clinical trial
临床试验设计的基本要素 临床试验的基本原则
一、临床试验的基本要素
研究因素
受试对象 实验效应
（一）研究因素
研究因素（实验因素、处理因素），是根据研究目的施 加给研究对象的各种干预措施，包括物理因素、化学因
素和生物因素。如某种药物、某种手术方法等。
临床试验所应用的药物或措施，首先要有科学的证据， 要有临床前期的观察，证明其有效性和安全性，同时具 有一定的创新性。如果没有这些最基本的科学依据，任 何药物或措施是不容许用作临床试验的，因为临床试验
2 2 2(1.96 1.28) 1.8 n 272 2 (9.5 9.0)
（三）试验效应
干预措施作用于受试对象后产生的各种反应。
效应的大小是通过具体指标反映出来的，通过
指标分析便可对干预措施所产生的效果做出客
观的评价，所以在设计时应重视选择指标的问 题。
观察指标的选择
关联性
指选定的效应指标与所研究的问题有本质的联系，并能够确切 地反映干预措施的效应。确定指标的关联性可通过阅读文献， 结合专业知识分析推理，最可靠的办法是通过预试验或标准阳 性对照来验证。
特异性
特异性是指选定的指标对某一实验效应惟一有效。特异性高的 指标，易于揭示事物的本质特点而不易受其他因素的干扰。
经济可行
在考虑敏感度和特异度的基础上，应从多种方法中，选择经济 及可行性良好的测试方法和指标。
精确性
包括准确性和稳定性两层含义。准确性指测量值与真值的接近 程度，主要受系统误差的影响，稳定性指重复观察时测量值的 波动范围的大小，主要与随机误差有关。效应指标最好既准确 又稳定，其中首先是准确，其次是稳定。
clinicaltrials注册流程
clinicaltrials注册流程是一个由美国国家卫生研究院（NIH）赞助的在线注册数据库，旨在为公众提供有关临床试验的信息。
在这个数据库中，研究人员可以注册他们的临床试验，并提供有关试验的详细信息。
以下是注册流程的步骤：
1. 创建一个账户：在注册之前，您需要创建一个账户。
这个账户将允许您在上注册和管理您的临床试验。
2. 登录并开始注册：一旦您创建了账户，您可以登录并开始注册您的临床试验。
在注册过程中，您需要提供有关试验的详细信息，包括试验的目的、设计、参与者、招募和排除标准等。
3. 填写试验信息：在注册过程中，您需要填写试验的信息。
这些信息包括试验的标题、描述、研究设计、参与者、招募和排除标准等。
4. 提交试验信息：一旦您填写了试验的信息，您需要提交这些信息以进行审核。
审核过程可能需要几天时间，以确保您的试验信息符合的要求。
5. 更新试验信息：一旦您的试验信息被审核通过，您可以随时更新这些信息。
这包括添加或删除参与者、更改招募和排除标准等。
6. 完成注册：一旦您的试验信息被审核通过并更新，您的试验将被注册在上。
这将使公众能够访问您的试验信息，并了解您的研究。
是一个非常有用的工具，可以帮助研究人员注册和管理他们的临床试验。
通过遵循上述步骤，您可以轻松地注册您的试验，并使公众能够访问您的研究信息。
clinicaltrial 申请账号步骤
当选择“Complete”后， 需再点击“Approve”
当点击完“Approve” 后，需再点击 “Release”
注 意 事 项 当所有资料填写完成后，点击“Complete”,还需点 击“Approve” →“Release”。 数天后可于clinical trial 官网查询到你的项目创建信 息
点击进入查询
常 见 问 题
正确填写的方式
填写项目负责人
填写研究机构名称 填写项目负责人信息
正确填写方式 填写伦理委员会档案编号 填写伦理委员会具体名称
填写伦理委员会所述机构名 称 项目负责人信息
正确填写方式
填写监管机构名称
正确填写方式
填写Байду номын сангаас目负责人或项目管理人资料
正确填写方式
填写项目负责人信息，若有一个以上负责人， 也可无限新增
当所有资料填写完成后，会出现以下页面
点击OK
当点击完“OK”后可能会出现以下画面
其中符号含义如下：
若当次未完成登录所有资料，请勿选择 “Complete”。请返回至主菜单（Main Menu） 中选择“Modify”可检查未完成的资料，确定资 料还在你的账号中。
注 意 事 项 若要继续编辑或修改资料，请点击“Modify”进入后，选 择“Edit”继续编辑完成 选择“Logout”退出登录
1.Apply for PRS Organization Account 1.申请账号步骤
请输入以下网址： /ct2/applyaccount-org 进入申请界面
参照以下备注填入相关信息，准确无误后，提交申请，接受申请后将于2 各工作日后给予申请者包含所获账号的邮件反馈。
正确填写方式 1200字左右 2500字左右
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ID GROUP CENTER time1time2age AGE_G SEX 121##########25-Feb-20022712221##########08-Mar-2002603132111-Jun-193808-Mar-2002643241106-Jun-196908-Mar-2002331251106-Jan-194522-Jan-2002573161122-Feb-197822-Mar-20022412721##########05-Mar-2002261281101-Jul-196806-Mar-2002341192101-Mar-197608-Mar-20022611 101101-Jul-193908-Mar-20026332 111101-Feb-193708-Mar-20026532 122101-Oct-198409-Mar-20021711 1311##########30-Mar-20026331 142116-Jul-194602-Mar-20025631 1521##########09-Mar-20022112 161101-Jul-197603-Mar-20022612 1711##########30-Mar-20026431 182117-Mar-193823-Mar-20026431 192101-Mar-197309-Mar-20022911 201101-Apr-197013-Mar-20023211 2111##########14-Mar-20026431 221101-Oct-198218-Mar-20021911 232101-Jun-198118-Mar-20022111 2421##########20-Mar-20024522 2521##########28-Mar-20022711 262126-Oct-193821-Mar-20026331 271120-Jun-193922-Mar-20026331 2821##########29-Mar-20024421 291125-Jun-193830-Mar-20026431 3011##########29-Mar-20023412 311101-Jan-193923-Mar-20026332 322101-Mar-195225-Mar-20025031 3321##########27-Mar-20025531 341101-Jun-194027-Mar-20026231 352101-Jun-194208-Apr-20026031 361101-Jun-197110-Apr-20023111 3711##########05-Mar-20024322 3811##########05-Mar-20023922 391108-Jun-197210-Mar-20023012 402109-Feb-197413-Mar-20022812 412101-Mar-194017-Mar-20026232 422129-Oct-194918-Mar-20025232 431106-Jun-195421-Mar-20024822 4411##########23-Mar-20023212 452109-Jun-197223-Mar-20023012 461121-Oct-197724-Mar-20022412 4721##########26-Mar-20024522 482109-Jul-196826-Mar-20023412 4922##########01-Feb-20023112 5022##########14-Jan-20025631 511201-Feb-196016-Jan-20024222 522228-Jan-194430-Jan-20025831 5312##########05-Feb-20023621 541203-Apr-195731-Jan-20024521551219-Oct-194219-Jan-20025931 562225-Apr-197227-Jan-20023012 572228-Jul-193902-Feb-20026331 5812##########20-Feb-20025831 5922##########22-Feb-20027831 6012##########26-Feb-20024921 611221-Apr-196713-Jan-20023511 621213-Apr-197314-Jan-20022912 6322##########14-Jan-20023111 642211-Mar-197419-Jan-20022811 652212-Mar-197222-Jan-20023012 6612##########23-Jan-20023211 672217-Mar-195430-Jan-20024821 6812##########26-Feb-20025432 6922##########26-Feb-20026432 7012##########10-Mar-20022611 7122##########11-Mar-20025021 7212##########11-Mar-20027831 7312##########15-Mar-20025631 742207-Oct-198513-Apr-20021712 751212-Mar-194116-Apr-20026131 762205-Oct-197820-Mar-20022311 772210-Apr-196204-Apr-20024021 781207-Jul-194208-Apr-20026031 7922##########08-Apr-20023622 8012##########09-Apr-20023921 811214-Oct-194216-Apr-20026031 822212-Apr-194415-Apr-20025832 8322##########16-Apr-20024221 8412##########16-Apr-20025021 851204-Jul-197116-Apr-20023111 862211-Jul-197310-Apr-20022911 8722##########16-Apr-20024622 881213-Jul-194616-Apr-20025631 8922##########16-Apr-20024022 901203-Apr-196517-Apr-20023721 911212-Mar-195416-Jan-20024822 922202-Apr-196030-Jan-20024222 931211-Jul-196229-Jan-20024021 941205-Jun-194031-Jan-20026231 952203-Jul-195603-Feb-20024621 962220-Mar-195705-Feb-20024521 971202-Mar-195824-Jan-20024421 981209-Feb-196431-Jan-20023821 9922##########31-Jan-20022911 10022##########03-Feb-20022611 1011203-Jan-195403-Mar-20024822 1022215-Apr-195503-Mar-20024722 10322##########30-Mar-20023621 10412##########30-Mar-20023822 10512##########02-Apr-20024721 1062207-Jul-197504-Apr-20022711 1071202-Feb-196607-Apr-20023622 10822##########07-Apr-20023821 1091210-Oct-195402-Apr-200247211102207-Jul-195107-Apr-20025131 11122##########10-Apr-20024121 1121217-Apr-195211-Apr-20025021 1132218-Jan-195215-Apr-20025031 1141219-Apr-197417-Apr-20022811 1151210-Jun-197824-Mar-20022411 1162230-Jun-195730-Mar-20024521 1171203-Jun-197204-Apr-20023011 1181210-Jan-196308-Apr-20023921 1192228-Apr-197010-Apr-20023211 1202212-Oct-197210-Apr-20022912 12112##########30-Jan-20025332 12222##########07-Mar-20023412 12312##########24-Mar-20024121 1241222-Mar-195327-Mar-20024921 1252202-Oct-195128-Mar-20025031 1262202-Feb-195904-Apr-20024321 1272220-Mar-196606-Mar-20023621 12822##########07-Mar-20022711 1291201-Jun-197913-Mar-20022311 1301201-Jun-196214-Mar-20024021 1311201-Apr-197721-Mar-20022511 1322201-Oct-196422-Mar-20023721 13312##########22-Mar-20024521 13412##########22-Mar-20024421 1352214-Feb-196909-Apr-20023311 13612##########10-Apr-20025432 13722##########12-Apr-20024022 13822##########15-Apr-20023212 1392203-Feb-196021-Mar-20024221 1401204-Apr-197304-Apr-20022912 1411223-Apr-194512-Apr-20025732 1422215-Oct-195213-Apr-20024921 1432215-Apr-195618-Apr-20024622 14412##########18-Apr-20024721HT WT SBP DBP PULSE ECG UPAIN1HB1 1644514.08.07902139 1746517.09.06811156 1584920.09.08002105 1645413.010.07912159 1777516.010.07311126 1615315.08.07601125 1706516.010.07001135 1686816.010.06002156 1778018.010.07011149 1625318.010.08012137 1607018.010.0701194 1706017.010.08002125 1675122.08.07712156 1747017.011.08112140 1666114.48.08602109 1626013.09.0901186 1787521.09.07302146 1685318.512.07302163 1808020.011.0900192 1757418.010.06302153 1727521.012.08202135 1706517.010.07503138 1797017.010.07001152 1635816.010.06502140 1756815.09.07202126 1757016.510.56912129 1808020.011.07312144 1736816.09.07411174 1736415.08.9771298 1666515.09.08002123 1606319.011.09012124 1707020.011.09701144 1687020.011.07501151 1707320.011.08003168 1706217.010.56001191 1767218.010.07501166 1666215.010.07602136 1596015.010.08201122 1565511.07.07802135 1626416.010.0770270 1587816.010.08602134 1557813.09.08001126 1626618.012.08401116 1636619.012.08002139 1646715.010.0770291 1605614.010.0760295 1617215.09.08002116 1555816.010.08402120 1565816.011.06501137 1717418.010.27202140 1615117.010.07001165 1696313.09.06202143 1696518.012.07501132 1657612.010.076021201757515.011.07502141 1675312.09.06702167 1797513.010.07002143 1675519.010.07102136 1757520.011.07502148 1716018.011.07002146 1767814.010.07202132 1726512.09.07002125 1817915.010.07701123 1736514.510.07801146 1696214.010.06901160 1788015.010.57603193 1787414.010.07501114 1586714.011.06002139 1567215.011.06001141 1716513.010.07202135 1726818.010.07202156 1768017.012.06802118 1716819.511.27202110 1605015.010.07001117 1666518.012.07003144 1746614.08.06901138 1706517.211.57201120 1696819.011.06502139 1585414.09.07002110 1837014.09.07202163 1747015.412.07802156 1657514.010.07203139 1786512.410.06002145 1675713.010.06602121 1767212.010.07503145 1787413.09.57002136 1686815.510.06802108 1788217.010.07203118 1587214.510.06202113 1787214.010.07701115 1596015.09.07601129 1556818.011.06901131 1727719.012.06502139 1717919.012.06502140 1717218.010.06801112 1687018.611.06501136 1657419.010.06802144 1808220.013.07202144 1738417.010.06502157 1768017.010.07003126 1607019.012.06801122 1585419.010.07001142 1656318.010.06802143 1757817.011.07102160 1687720.012.06802147 1808016.08.06402152 1706117.010.07002155 1687817.010.07002126 1757018.010.069021441696119.511.06802136 1727019.011.06502133 1706014.08.06302147 1716214.010.06502140 1656015.08.06402131 1807515.08.07002122 1687220.012.06502126 1707216.010.06902159 1585814.010.07001138 1585114.08.06801140 1646216.59.47502133 1586018.511.57202133 1615115.09.07202134 1748019.512.07602127 1707820.012.07002140 1707820.412.07102163 1696416.08.07401161 1707418.511.06802118 1736214.08.06802137 1766814.57.56802140 1726815.08.06801128 1798717.09.07003123 1666617.011.07102135 1798819.810.47002152 1687018.611.07801131 1706514.09.08001130 1646321.012.06402129 1726016.09.07502129 1616216.010.07001134 1778720.411.07002122 1666016.59.58001149 1575219.511.47801131 1726819.511.06801125 1684813.010.06901143 1807814.09.07802138RBC1WBC1PLT1UPAIN2HB2RBC2WBC2PLT24.46 4.501751140 4.757.002755.776.302461139 4.449.702323.09 6.00368299 3.329.303995.24 2.902360123 4.18 4.402293.349.902131107 3.6011.002773.938.301980118 3.69 6.802404.907.50163192 3.98 6.603325.60 5.102422156 5.60 5.102425.3111.2015811619.90 5.442424.105.601690130 4.406.402123.32 3.9026001234.40 4.603124.547.9032421515.468.703624.90 6.5020201565.2616.301384.32 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6.74290 4.63 6.802350133 4.537.10186 4.6513.901731133 4.7510.70219 4.38 5.601590127 4.03 5.40172 4.657.502220150 5.29 6.902204.669.9018521675.50 5.701615.288.001841136 4.517.72287 4.08 5.801882114 3.876.00183 4.767.802671138 4.507.10183 4.869.501980137 4.497.30199 4.38 6.901660141 4.627.50189 4.23 6.701840133 4.16 6.902074.387.101791128 4.23 6.701815.327.902440127 4.226.20212 4.157.002030126 4.48 5.90200 4.20 6.972221131 4.269.20247 4.53 5.692390126 4.559.57173 4.20 6.732181131 4.579.32263 4.73 5.992321132 4.23 6.812584.13 6.501882125 4.305.001855.10 4.401320140 4.53 4.83262 4.326.501660130 4.42 6.45189 4.06 5.772151130 4.43 6.03272 4.99 6.512850147 4.587.83280 4.417.053122136 4.747.32292benefit AE HB_D00-1.000117.0000 6.001036.000019.00007.000043.00 #NULL!#NULL!0.0000-12.00107.0010-29.0000-26.00100.000047.0000-14.0010-3.001028.000019.0000-15.001010.001018.0010-16.0000 2.0001 2.0000-3.00000.001010.0000-3.00100.0010-10.001041.000033.0000 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