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共用题干
Clinical Trials
1. Many clinical trials are done to see if a new drug or device is safe and effective for people to use.Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective,easier to use,and/or decrease side effects.Sometimes,studies are done to learn how to best use the treatment in a different population,such as children,in whom the treatment was not previously tested.
2. It is important to test drugs and medical products in the people they are meant to help.It is also important to conduct research in a variety of people because different people may respond differently to treatments.Some people participate in clinical trials because they have exhausted standard treatment options .Other people participate in trials because they want to contribute to the ad-vancement of medical knowledge.
3. The FDA(食品及药物管理局)works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial.Although efforts are made to control the risks to clinical trial participants,some risks may be unavoidable because of the uncertainty inherent(内在的)in medical research studies involving new medical treatments.
4. People should learn as much as possible about the clinical trials that interest them.They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective(预期的)participants should understand what happens during the trial ,the type of health care they will receive,and any costs to them.Anyone considering a clinical trial should also know that there are benefits and risks associated with participating.

Paragraph 2______
A: Are clinical trials safe?
B: What are clinical trials?
C: What should people know before participating in a clinical trial?
D: Who should consider clinical trials and why?
E: Where are clinical trials conducted?
F: Why are clinical trials done?

参考答案

参考解析
解析:第一段主要讲为什么要进行临床试验,其中谈到要研究如何安全有效地使用新药物或新仪器,如何使用方便并减少副作用,或用于不同人群等。


第二段主要讲什么人为什么参加临床试验,比方说,要观察不同人群的不同疗效,有的人已没有别的方法治疗,也有的人要为医疗事业作贡献等。


第三段主要讲参加临床试验的安全性问题。尽管FDA等会做出努力,但是新治疗方法的不确定性是不可避免的。


第四段主要讲人们参加临床试验前可以与有关医务人员充分讨论问题,了解试验的详情以及试验的利弊等。


短文第一句就说到,新药物或新仪器用于人体是否安全有效需要进行临床试验。


第二段第三句说到,有些人对于常规的治疗方法已无可选择,所以参加临床试验,当然就是他们的唯一希望了。


第三段第一句说到,FDA要保证,在人们决定是否参加临床试验的时候要获得可靠信,息。


整个第四段说到,准备参加临床试验的人们要尽可能多地了解有关临床试验的情况。
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考题 共用题干 Cancer Drug Trials Often Halted EarlyAn increasing number of clinical trials for new cancer treatments are being halted before the risks and benefits have been fully evaluated,say Italian researchers,who warn that this growing trend could put patients at risk of harm from new therapies rushed into use.The researchers looked at 25 randomized,controlled clinical trials that were stopped ear-ly because the treatments had started to show benefit to patients.“When we analyzed 25 trials over a 10-year period between 1997 and 2007,we found a consistent increase in prematurely stopped trials一more than 50 percent were stopped within the last three years,”study co-author Giovanni Apolone said at a news conference Tuesday.Of 14 trials halted early and published between 2005 and 2007,the researchers found that 11(79 percent)of them were used to support drug approval applications submitted to the European Medicines Agency and the U.S.Food and Drug Administration.“This suggests a strong commercial component in stopping trials prematurely.In fact, this strategy could guarantee quicker access to the market for companies.On the other hand, a quicker clinical drug development may lead to an ‘immature’benefit/risk balance of new drugs,”Apolone said.He and his colleagues“are aware that trials stopped early because they are showing ben-efit may result in identification of promising new treatments for patients.However,findings obtained following this strategy should be considered to be preliminary results that require subsequent confirmation.”It can take several years for the long-term benefits or harmful side effects of a new treat-ment to become apparent, Apolone noted, but the average duration(持续时间)of the 25 studies he and his colleagues analyzed was 30 months,with a range from 12 to 64 months.They also found that at the time five of the studies were stopped,they'd enrolled less than 40 percent of the total number of patients planned for final analysis.“Clinical trials need to stop early for superior benefit whenever there's proof beyond rea- sonable doubt that the new treatment really is superior.That would be an ethical obligation,” Stuart Pocock,a professor of medical statistics at the London School of Hygiene and Tropi-cal Medicine in the United Kingdom,said at the news conference.“However,too many trials are stopped early claiming efficacy(功效)without strong evidence being available.”The number of prematurely stopped clinical trials has increased recently.A:RightB:WrongC:Not mentioned

考题 共用题干 Cancer Drug Trials Often Halted EarlyAn increasing number of clinical trials for new cancer treatments are being halted before the risks and benefits have been fully evaluated,say Italian researchers,who warn that this growing trend could put patients at risk of harm from new therapies rushed into use.The researchers looked at 25 randomized,controlled clinical trials that were stopped ear-ly because the treatments had started to show benefit to patients.“When we analyzed 25 trials over a 10-year period between 1997 and 2007,we found a consistent increase in prematurely stopped trials一more than 50 percent were stopped within the last three years,”study co-author Giovanni Apolone said at a news conference Tuesday.Of 14 trials halted early and published between 2005 and 2007,the researchers found that 11(79 percent)of them were used to support drug approval applications submitted to the European Medicines Agency and the U.S.Food and Drug Administration.“This suggests a strong commercial component in stopping trials prematurely.In fact, this strategy could guarantee quicker access to the market for companies.On the other hand, a quicker clinical drug development may lead to an ‘immature’benefit/risk balance of new drugs,”Apolone said.He and his colleagues“are aware that trials stopped early because they are showing ben-efit may result in identification of promising new treatments for patients.However,findings obtained following this strategy should be considered to be preliminary results that require subsequent confirmation.”It can take several years for the long-term benefits or harmful side effects of a new treat-ment to become apparent, Apolone noted, but the average duration(持续时间)of the 25 studies he and his colleagues analyzed was 30 months,with a range from 12 to 64 months.They also found that at the time five of the studies were stopped,they'd enrolled less than 40 percent of the total number of patients planned for final analysis.“Clinical trials need to stop early for superior benefit whenever there's proof beyond rea- sonable doubt that the new treatment really is superior.That would be an ethical obligation,” Stuart Pocock,a professor of medical statistics at the London School of Hygiene and Tropi-cal Medicine in the United Kingdom,said at the news conference.“However,too many trials are stopped early claiming efficacy(功效)without strong evidence being available.”The 25 trials involved roughly the same number of participants.A:RightB:WrongC:Not mentioned

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考题 共用题干 Using HIV Virus to Cure CancerScientists are planning to use human immuno deficiency(免疫缺陷)virus(HIV) , one of mankind's most feared viruses,as a carrier of genes which can fight cancer and a range of diseases that cannot be cured.The experts say HIV has an almost perfect ability to avoid the body's immune(免疫的)defenses, making it ideal for carrying replacement genes into patients'bodies,according to the Observer.A team at the California-based Salk Institute,one of the world's leading research centers on biological sciences,has created a special new breed of HIV and has started negotiations with the U.S.Food and Drug Administration(FDA)to begin clinical gene therapy(治疗)trials this year.The first trials are expected to involve patients suffering from cancers that cannot be cured by surgery although project leader Professor Inder Verma said the HIV technique would have“far wider applications”.The plan remains very likely to cause controversy since it involves making use of a viruswhich has caused more than 22 million deaths around the world in the past two decades.Verma said that the idea of using HIV for a beneficial purpose was“shocking”but the fierce nature of HIV had disappeared by having all six of the potentially deadly genes removed.Illnesses such as various cancers are caused when a gene in a patient's body fails to work properly.In the past two years, breakthroughs in genetics(遗传学)have led gene therapy sci-entists to try and replace the genes that do not function normally.Unfortunately,the body's immune defenses have been known to attack the modified genes and make them lose their effects before they can start their task and progress in the field has been held up by the lack of a suitable carrier.The HIV virus has the ability to escape from,and then destroy,the immune defense cells designed to protect our bodies and this makes it attractive to scientists as a way of secretly conveying replacement genes into patients'bodies.Other countries are also expected to begin clinical gene therapy trials soon.A:RightB:WrongC:Not mentioned

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考题 临床实践指南(clinical practice guideline)

考题 临床试验(clinical trial)

考题 临床证据手册(handbook of clinical evidence)

考题 名词解释题临床试验(clinical trial)

考题 名词解释题临床实践指南(clinical practice guideline)

考题 名词解释题药物临床试验(drug clinical trial)

考题 名词解释题多中心临床试验(multicenter clinical trial)

考题 名词解释题临床证据手册(handbook of clinical evidence)