临床试验词汇汇编
Glossary of Clinical Trials Terms
The following glossary was prepared to help the consumer become familiar with many of the common terms ud in clinical trials.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
ADVERSE REACTION不良反应（不良事件）:(Adver Event.) An unwanted effect caud by the administration of drugs. Ont may be sudden or develop over time (See Side Effects).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Side Effects）。
ADVOCACY AND SUPPORT GROUPS倡导和支持的群体: Organizations and groups that actively support participants and their families with valuable resources, including lf-empowerment and survival tools.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。
APPROVED DRUGS批准的药物: In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves veral steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA
approval/rejection of application (See Food and Drug Administration).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Food and Drug Administration）
ARM组:Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more (See Randomized Trial).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Randomized Trial）
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。Information gathered at the beginning of a study from which variations found in the study are measured. 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。A known value or quantity with which an unknown is compared when measured or assd. 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。The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baline values.
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Blind and Randomization） When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization (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。A randomized trial is "Blind" if the participant is not told which arm of the trial he is on.
A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. (See Single Blind Study and Double Blind Study).
CLINICAL临床: Pertaining to or founded on obrvation and treatment of participants, as distinguished from theoretical or basic science.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。
CLINICAL ENDPOINT临床终点: See Endpoint.
CLINICAL INVESTIGATOR临床调查员：一位负责实施临床试验议定书的医学研究员。A medical rearcher in charge of carrying out a clinical trial's protocol.
CLINICAL TRIAL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。 clinical trial is a rearch study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical rearch and rearch studies) are ud to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phas: Pha I tests a new drug or treatment in a small group; Pha II expands the study to a larger group of people; Pha III expands the study to
an even larger group of people; and Pha IV takes place after the drug or treatment has been licend and marketed. (See Pha I, II, III, and IV Trials).
COHORT队列: In epidemiology, a group of individuals with some characteristics in common.在流行病学，一组具有医学共同特征的个体。
COMMUNITY-BASED CLINICAL TRIAL 以社区为基础的临床试验(CBCT): A clinical trial conducted primarily through primary-care physicians rather than academic rearch facilities.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。
COMPASSIONATE USE使用同情:A method of providing experimental therapeutics prior to final FDA approval for u in humans. This procedure is ud with very sick individuals who have no other treatment options. Often, ca-by-ca approval must be obtained from the FDA for "compassionate u" of a drug or therapy.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。
COMPLEMENTARY AND ALTERNATIVE THERAPY补充和替代治疗: Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly u to promote well-being or treat health conditions. Examples include acupuncture, herbs, etc. Internet Address：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
v.
COMPLETED补充: See Recruitment Status
CONFIDENTIALITY REGARDING TRIAL PARTICIPANTS关于受试者保密: Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants' connt to the u of records for data verification purpos should be obtained prior to the trial and assurance must be given that confidentiality will be maintained.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:A specific circumstance when the u of certain treatments could be harmful.在特定的环境中当使用某种治疗可能是有害的。
CONTROL对照: A control is the nature of the intervention control.对照的本质是干预对照。
CONTROL GROUP对照组: The standard by which experimental obrvations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo该标准由实验结论进行评估。在很多临床试验中，一组病人将被使用一种试验的药物或治疗，而对照的一组被使用任何一种标准的疾病治疗或安慰剂。 (See Placebo and Standard Treatment).
CONTROLLED TRIALS对照试验: Control is a standard against which experimental obrvations ma
y be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the dia or a placebo.对照是一个标准对试验结果可进行评估。在临床试验中，一组受试者使用一种试验药物，而另一组（对照组）使用任何一种标准的疾病治疗或安慰剂。
DATA SAFETY AND MONITORING BOARD数据安全和监测委员会 (DSMB): An independent committee, compod of community reprentatives and clinical rearch experts, that reviews data while a clinical trial is in progress to ensure that participants are not expod to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved.一个独立的委员会，由社区专家和临床研究专家组成，他们审阅数据同时在临床试验进展过程中确保受试者不会受到不必要的危险。如果存在安全顾虑或已经实现实现试验目标，数据安全和评审委员会可以建议停止试验。
DIAGNOSTIC TRIALS诊断试验: Refers to trials that are conducted to find better tests or procedures for diagnosing a particular dia or condition. Diagnostic trials usually include people who have signs or symptoms of the dia or condition being studied.指的是为了发现更好的测试或程序来诊断一种特别的疾病或状况而开展的试验。诊断试验通常包括有疾病症状或体征，或出现被研究的状况的群体。
DOSE-RANGING STUDY剂量测距研究: A clinical trial in which two or more dos of an agent (such as a drug) are tested against each other to determine which do works best and is least harmful.临床试验在两个或更多的作用剂（如药物）剂量被逐个测试以确定哪个剂量作用最好，哪个剂量危害性最小。
DOUBLE-BLIND STUDY双盲研究: A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the
expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study. See Blinded Study, Single-Blind Study, and Placebo.参与的个人及研究人员都不清楚哪个受试者正在接受试验药物，哪个正在接受安慰剂（或另一种治疗）的情况下设计的临床试验。双盲试验被认为是产生客观结果，因为医生和受试者关于试验药物的预期不能影响结果。也叫双蒙蔽研究。
DOUBLE-MASKED STUDY双蒙面研究: See Double-Blind Study.
DRUG-DRUG INTERACTION药物的相互作用:A modification of the effect of a drug when administer
ed with another drug. The effect may be an increa or a decrea in the action of either substance, or it may be an adver effect that is not normally associated with either drug.在给予另一种药物的同时，将改变一种药物的药效。在任何一种物质的影响下，药效可能增加或降低，或可能是反作用因为它通常不与其它药物联合使用。
DSMB: See Data Safety and Monitoring Board.
EFFICACY效力:(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug pass efficacy trials if it is effective at the do tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Pha II clinical trials gauge efficacy, and Pha III trials confirm it （药物或治疗的）不论剂量一种药物或治疗所产生的最大结果。药物通过效力试验，如果在测试剂量它是有效地，并且可以对抗疾病是法定的。II 期效能度量和III 期试验证实是FDA的程序规定。(See Food and Drug Administration (FDA), Pha II and III Trials).
ELIGIBILITY CRITERIA合格标准: Summary criteria for participant lection; includes Inclusion and Exclusion criteria.概述受试者选择标准，包括纳入和排除标准。 (See Inclusion/Exclusion Criteria)
EMPIRICAL以观察或试验为依据: Bad on experimental data, not on a theory.基于实验数据，而不
是理论。
ENDPOINT终点: Overall outcome that the protocol is designed to evaluate. Common endpoints are vere toxicity, dia progression, or death.
该议定书的目的是评价总体结果，共同的终点是严重毒性，疾病进展或死亡。
ENROLLING招募: The act of signing up participants into a study. Generally this
