临床试验词汇汇编.pdf

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 used 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）: (Adverse Event.) An unwanted effect caused by the administration of drugs. Onset 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 self-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 several 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 assessed. 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