目的：探讨医院药师在药物临床试验中的作用。
RESULTS&CONCLUSION:Hospital pharmacists played a key role in clinical drug trial.
目的：保证药物临床试验的质量和保障受试者的权益。
OBJECTIVE: to guarantee the quality of the clinical drug trial and to ensure the interests of the subjects.
目的：依据循证医学观点，分析药物临床试验的质量。
Aim: to analyse the quality of clinical pharmaceutical trials according to the viewpoint of evidence-based medicine.
此部分重点介绍了：一、药物临床试验中受试者知情同意权的内容。
There're 3 parts in this article:The first part is an overview of the case.
结论：科学、严谨的药物临床试验设计，有助于获得真实、可靠的研究结果。
CONCLUSION: Scientific and strict clinical trials of drugs are helpful to obtain actual and reliable research results.
本文介绍了美国食品药品监督管理局关于抗菌药物临床试验非劣效设计的考虑。
This article is to introduce FDA's(Food and Drug Administration, FDA)considerations of non-inferiority design used in anti-bacterial drug clinical trial.
药物临床试验的目的就是要获得一种研究性药物用于人体的安全性和疗效结果。
The purpose of clinical trials research is to obtain safety and efficacy informations of a drug for human.
目的分析药物临床试验中影响受试者脱落的主要因素，探讨降低受试者脱落率的管理方法。
Objective To analyze main causes of drop-out in drug clinical trial and explore the methods of management in reducing its rate.
为了使得这些参考信息真实可信，传统的药物临床试验必须有所改进，以适合进行经济学评价。
In order to make this Reference information authentic, traditional clinical trials must be improved to fit to carry out economic evaluation.
药物临床研究必须经国家药品监督管理局批准后实施，必须执行《药物临床试验质量管理规范》。
Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control of Clinical Trial of drugs.
统计分析是药物临床试验整个过程中的一个重要环节，规范化的统计分析能真实地揭示药物的性能。
Statistical analysis is an important step in clinical drug trial and standard statistical analysis can reveal the true characteristics of drugs.
所以您能否临床研究中受益与否或受益大小可能和研究药物临床试验前的研究结果以及试验所处的期别有关。
So whether you can benefit from it or not is related to the result of the research before the clinical trial and the phase of the clinical trial.
方法：结合笔者多年的临床研究工作管理经验，对药物临床试验质量的关键环节和控制措施进行探讨并提出建议。
METHODS:According to the experience of author on clinical research management in many years, key step and control measure of drug clinical trials were explored to put forward recommendations.
本文主要阐述了抗菌药物临床试验技术指导原则重新撰写的原因、撰写程序、撰写中参考的文献资料及撰写中所关注的有关问题。
This article is to describe the causes, procedures, references, and some important consideration in drafting out new guidance for clinical trials of anti-bacterial drugs.
去年十一月份证券交易委员会机构指控一个法国医生非法向一个对冲基金提供内幕消息，这是关于某个药物临床试验过程中导致一起死亡的消息。
Last November the agency charged a French doctor for allegedly tipping off a trader at a hedge fund about a death in a clinical drug trial.
组蛋白脱乙酰基酶抑制剂已被证实具有抗肿瘤作用，多种有关组蛋白脱乙酰基酶抑制剂的药物临床试验正在进行中，以期成为治疗宫颈癌的一个新方向。
HDI has been proved to have antitumor activities and a number of clinical trials relating to HDI are in progress. It is expected that HDI becomes a new therapy of cervical cancer.
他们在临床试验中一直接受这种药物的治疗。
法国制药公司赛诺菲-安万特也在就一种口服药物特立氟胺开展大型临床试验。
France's Sanofi-Aventis is carrying out large clinical trials of an oral drug called teriflunomide.
辉瑞计划马上开始对一种肺癌药物的最后阶段的临床试验。
It plans soon to start a late-stage clinical trial of a drug for lung cancer.
研究队伍用美国的《自由信息法》得到了四种药物的三十五份未出版的临床试验报告。
The team used an American law, the Freedom of Information Act, to get unpublished reports on thirty-five clinical trials of four drugs.
到时这些病人就有可能有资格参加临床试验，接受药物治疗。
These patients may then qualify to participate in clinical trials for medications that treat Alzheimer's.
本周二美国食品药品监督管理局在其网站张贴了关于辉瑞公司实施的一项不知名药物的临床试验的警告。
The FDA posted a warning letter on its Web site Tuesday concerning clinical trials of an unnamed drug that the agency said was sponsored by Pfizer.
如果人身上的表现也是如此的话，那么，现在许多临床试验的药物可能因此而被证明是无效的。
If that is true in people, too, many more drugs now in clinical trials may prove to be ineffective.
据制药行业几大巨头的说法，目前约有860种癌症药物正在进行临床试验。
About 860 cancer drugs are being tested in clinical trials, according to the pharmaceutical industry's main trade group.
其他挑战包括需要就儿科药物开展更多的临床试验和研究。
Other challenges include the need for more clinical trials and research to be carried out on paediatric medicines.
为了满足对儿童药物的研究需要，加强儿科临床试验研究的质量和数量至关重要。
In order to address the research needs for children's medicines, strengthening the quality and quantity of paediatric clinical trials research is essential.
新药物在临床试验期间接受有限的安全性评估后，即正式注册并投放市场；在大规模普遍使用过程中，只能出现极为罕见的意外的副作用个案。
New medicines are registered and enter the market with limited safety evaluation during clinical trials; rare unexpected side effects can only be detected during large-scale use.
如今，药物的试验和审批需要耗费十几年时间，而在进入人类临床试验阶段的药物中，有90%都以失败告终。
Drugs now take a dozen years to be tested and approved, and 90% of meds that reach human clinical trial fail.
这些信息会被用来寻找针对这些机制的药物，进而再次用于临床，进行临床试验。
That information will be used to find drugs to target those mechanisms that will then be brought back into the clinic to be tested in clinical trials.
这些信息会被用来寻找针对这些机制的药物，进而再次用于临床，进行临床试验。
That information will be used to find drugs to target those mechanisms that will then be brought back into the clinic to be tested in clinical trials.
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