Monday, March 16, 2015

Commonly Used Clinical Trial Terms in English and Their Chinese Translations; List of Regulatory Guidance for Clinical Trials in China

Friends sometimes ask me about the Chinese translations of the clinical trial terms. Some of the terms are new in Chinese. They did not exist in Chinese until recent years when the drug development and clinical trials had been rapidly expanding in China. It would be useful to list the commonly used terms in clinical trials and provide the corresponding translations. These translations are based on the regulatory documents issued by SFDA (China Food and Drug Administration). Some of the translations are different between the mainland China and the Taiwan.
English
Chinese (中文)
Active Control
阳性对照
Adaptive Design
自适应设计
Absorption, Distribution, Metabolization, and Elimination (ADME)
吸收、分布、代谢、清除
Adverse Event
不良反应
Alpha-spending function
α消耗函数
Alternative Hypothesis
备择假设
Area Under Curve (AUC)
曲线下面积
Audit
稽查
Audit Trail
稽查踪迹
Baseline Value
基线值
Bias
偏倚
Bioavailability
生物利用率
Bioequivalence
生物等效性
Biomarker
生物标志物
Biosimilar
生物类似药
Blind Review
盲态审核
Blinding/Masking
设盲
Candidate Product (Proposed Product)
候选药
Case Report Form
病例报告表
CIOMS
国际医学科学组织委员会
Clinical Trial
临床试验
Maximum Concentration (Cmax)
达峰浓度
Minimum Concentration (Cmin)
谷浓度
Coding Dictionary
术语表
Company Core Data Sheet (CCDS)
公司核心数据表
Common Technical Document (ICH-CTD)
通用技术文件
Common Toxicity Criteria (CTC)
常见毒性反应标准
Comparative Study
比对试验
Confidence Interval
可信区间
Confirmatory Trial
验证性试验
Concomitant Medication
并用药品
Confidentiality
保密性
Conflict of Interest
利益冲突
Contract Research Organization
合同研究组织
Coordinating Investigator
协调研究者
co-primary endpoint
协同的主要疗效指标
Cross-over Design
交叉设计
Data and Safety Monitoring Board (DSMB)
数据与安全监查委员会
DiseaseFree Survival ,DFS
无病生存期
Progression-Free Survival ,PFS
无进展生存期
Dose Limited Toxicity, DLT
剂量限制性毒性
Double-Dummy
双模拟
Dropout
脱落
eCTD
电子化通用技术文件
Endpoint Assessment or Adjudication Committee (EAC)
终点判定委员会
Electronic Data Capture (EDC)
电子数据采集
Equivalence
等效性
Ethics Committee
伦理委员会
Exploratory Efficacy Endpoint
辅助疗效指标
Full Analysis Set
全分析集
Generic Product
仿制药
Good Clinical Practice (GCP)
临床试验质量管理规范
Half Life
半衰期
Health-related Quality of Life HRQoL
健康相关的生活质量
Highly Variable Drug
高变异性药
Hypothesis Test
假设检验
Immunogenecity
免疫原性
Independent Data Monitoring Committee (IDMC)
独立数据监察委员会
Indication
适应症
Individual Bioequivalence (IBE)
个体生物等效性
Informed Consent Form
知情同意书
Intention To Treat Principl
意向性分析原则
Interim Analysis
期中分析
Inspection
视察
Institutional Review Board
伦理委员会
Interaction
交互作用
Investigator
研究者
Investigator’s Brochure
研究者手册
Investigational Product
试验用药品
Investigational Medicinal Product (IMP)
临床试验用品药
Label
标签
last observation carried forward
结转
Lower Limit of quantitationLLOQ
定量下限
Maximal Tolerated Dose (MTD)
最大耐受剂量
Mean Residence Time (MRT)
平均滞留时间
Medical History
病史
Missing Data
缺失数据
Monitor
监查员
Multicentre Trial
多中心临床试验
Non-compliance/Violation
不依从/违背方案
No Observed Adverse Effect Level (NOAEL)
未观察到不良反应的剂量
Non-inferiority
非劣(效)性
Open Label
开放
Originator Biologic
原研产品
Overall Survival  OS
总生存期
Patient-reported Outcomes (PRO)
患者自评结果
Per Protocol Set
符合方案集
Pivotal Study
关键性临床试验
Placebo
安慰剂
Pharmacodynamics (PD)
药效动力学
Pharmacokinetics (PK)
药代动力学
Pharmacovigilence (PV)
药物警戒
Population Bioequivalence (PBE)
群体生物等效性
Population Pharmacokinetics (PPK)
群体药效动力学
post hoc
事后的
Primary Efficacy Endpoint
主要疗效指标
Primary Efficacy Variable
主要疗效变量
Protocol
试验方案
Protocol Amendment
试验方案修正案
Periodic Safety Update Reports for Marketed Drugs (PSUR)
上市药品定期安全性更新报告
PK/PD Model
药代/药效模型
RelationshipCausality
关联性
Randomization
随机
Reference Product
参照药
Sample Size
样本量
Secondary Efficacy Endpoint
次要疗效指标
Sequelae
后遗症
Serious Adverse Event
严重不良反应
Single-arm Design
单臂设计
Sponsor
申办者
Standard Operating Procedure
标准操作规程
Statistical Analysis Plan (SAP)
统计分析计划
Steady State
稳态
Superiority
优效性
Surrogate Endpoint and Surrogate Variable
替代指标
Survival analysis
生存分析
Time to Maximum Concentration (Tmax)
达峰时间
Unexpected  Adverse Event
非预期不良事件
Washout period
清洗期
In collecting the Chinese translations for the commonly used clinical trials, I have to review the regulatory guidance issued by SFDA. It is good to have the links below for references. 


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