多中心临床试验（multicenter clinical trial）
题目
多中心临床试验（multicenter clinical trial）
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更多“多中心临床试验（multicenter clinical trial）”相关问题
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第1题：
扩大的多中心临床试验是
正确答案：B
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第2题：
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 group,
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 advancement 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.Reliable information should be available to_________.
A: for some patients
B: before participation
C: in humans
D:medical knowledge
E: during the trial
F: candidates for clinical trials答案：F解析： -
第3题：
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.Clinical trials provide the only hope______.
A: candidates for clinical trials
B: during the trial
C: medical knowledge
D: in humans
E: before participation
F: for some patients答案：F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。 -
第4题：
对目标适应证患者（多中心试验）治疗作用的初步评价（ ）A：I期临床试验
B：Ⅱ期临床试验
C：Ⅲ期临床试验
D：Ⅳ期临床试验
E：V期临床试验答案：B解析：I期临床试验是初步的临床药理学及人体安全性评价试验阶段。试验对象主要为健康受试者，样本数一般为20-30例。Ⅱ期临床试验是对治疗作用的初步评价阶段。实验对象为目标适应症患者，试验样本数多发病不少于300例，其中主要病种不少于100例，要求多中心即在3个及3个以上医院进行。Ⅳ期临床试验上市后药品临床再评价阶段。试验样本数常见病不少于2000例。 -
第5题：
对目标适应证患者（多中心试验）治疗作用的初步评价（）
AⅠ期临床试验
BⅡ期临床试验
CⅢ期临床试验
DⅣ期临床试验
EⅤ期临床试验
B
略 -
第6题：
评价干预措施效果的最佳证据来自（）
- A、一个随机对照临床试验
- B、一个多中心随机对照临床试验
- C、一个多中心临床试验
- D、传统的文献综述
- E、随机对照临床试验的系统综述和meta分析
正确答案:E -
第7题：
多中心试验，各中心临床试验样本大小及中心间的分配应符合（）的要求。
正确答案:统计分析 -
第8题：
多中心临床试验要求各中心同期进行临床试验。
正确答案:正确 -
第9题：
临床试验（clinical trial）
正确答案:指任何在人体（病人或健康志愿者）进行药物的系统性研究，以证实或揭示试验药物的作用、不良反应及/或试验药物的吸收、分布、代谢和排泄，目的是确定试验药物的疗效与安全性。 -
第10题：
判断题多中心临床试验由申办者总负责，并作为临床试验各中心间的协调人。A对
B错
正确答案： 对解析： 暂无解析 -
第11题：
名词解释题药物临床试验（drug clinical trial）正确答案： 任何在人体（病人或健康志愿者）进行药物的系统性研究，以证实或揭示药物的作用、药物不良反应及/或其吸收、分布、代谢和排泄，目的是确定药物的疗效及安全性。解析： 暂无解析 -
第12题：
判断题多中心临床试验要求各中心同期进行临床试验。A对
B错
正确答案： 对解析： 暂无解析 -
第13题：
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?答案：D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。 -
第14题：
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.Learn as much as you can about a clinical trial______.
A: candidates for clinical trials
B: during the trial
C: medical knowledge
D: in humans
E: before participation
F: for some patients答案：E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。 -
第15题：
循证药物信息的主体是A:临床经验
B:多中心、样本对照的临床试验
C:随机、双盲、对照的临床试验
D:多中心、大样本、随机、双盲、对照的临床试验
E:多中心、随机、双盲、对照、数理统计的临床试验答案：D解析： -
第16题：
循证药物信息的主体是（ ）A：多中心、大样本、随机、双盲、对照的临床试验
B：多中心、双盲、对照的临床试验
C：随机、双盲、对照的临床试验
D：多中心、大样本的临床试验
E：大样本、对照的临床试验答案：A解析：循证医学的主要来源是随即对照试验和荟萃分析。大样本、多中心、随机对照的临床试验是评价一种治疗方案的最佳方法，也是方法有效性和安全性最可靠的依据。 -
第17题：
以下说法错误的为（）
- A、多中心临床试验要求同时开始，但可以不同时结束。
- B、多中心临床试验由申办者总负责，并作为临床试验各中心间的协调人。
- C、多中心临床试验由一位主要研究者总负责，并作为临床试验各中心间的协调人。
- D、多中心临床试验方案及附件起草后由各中心主要研究者共同讨论制定，经申办者同意，伦理委员会批准后执行。
正确答案:A,B -
第18题：
多中心临床试验由一位主要研究者总负责，并作为临床试验各中心间的协调人。
正确答案:正确 -
第19题：
多中心临床试验由申办者总负责，并作为临床试验各中心间的协调人。
正确答案:错误 -
第20题：
以下说法正确的为（）
- A、多中心临床试验应建立标准化的评价方法，试验中所采用的实验室和临床评价方法均应有质量控制，或由多中心实验室进行。
- B、多中心临床试验的数据资料应集中管理与分析，并建立数据传递与查询程序。
- C、多中心临床试验应建立管理办法以使各试验中心的研究者遵从试验方案，包括在违背方案时中止其继续参加试验的措施。
- D、在多中心临床试验中应加强监查员的职能
正确答案:A,B,C,D -
第21题：
名词解释题临床试验（clinical trial）正确答案： 指任何在人体（病人或健康志愿者）进行药物的系统性研究，以证实或揭示试验药物的作用、不良反应及/或试验药物的吸收、分布、代谢和排泄，目的是确定试验药物的疗效与安全性。解析： 暂无解析 -
第22题：
多选题以下说法错误的为（）A多中心临床试验要求同时开始，但可以不同时结束。
B多中心临床试验由申办者总负责，并作为临床试验各中心间的协调人。
C多中心临床试验由一位主要研究者总负责，并作为临床试验各中心间的协调人。
D多中心临床试验方案及附件起草后由各中心主要研究者共同讨论制定，经申办者同意，伦理委员会批准后执行。
正确答案： B,C解析： 暂无解析 -
第23题：
名词解释题多中心临床试验（multicenter clinical trial）正确答案： 由多位研究者按同一试验方案在不同地点和单位同时进行的临床试验。各中心同期开始与结束试验。多中心试验由一位主要研究者总负责，并作为临床试验各中心间的协调研究者。解析： 暂无解析