On Biostatistics and Clinical Trials: 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
Disease－Free 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 quantitation，LLOQ	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
Relationship（Causality）	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.