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What is a clinical trial?

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Clinical research refers to all academic activities involving human participants that contribute to knowledge in healthcare and that can be generalized to the wider population. Clinical research also includes clinical trials as described in the Pharmaceutical Affairs Law, the Bioethics and Safety Act, the International Council for Harmonization (ICH)/Good Clinical Practice (GCP) guidelines, and US Federal Regulations (21CFR50 / 45CFR46).

Considerations for Clinical Trial

1  Clinical studies are conducted in a variety of ways. The research officer must follow the prescribed rules in selecting respondents who will participate in the study. They should be able to participate in research that is appropriate for the nature of the study.

1  If the respondent is eligible for the clinical study, their doctor may ask for their participation.

1  Relevant clinical trials can be identified online.

1  Those who wish to participate in a clinical study must agree and provide fully-informed consent.

1  Clinical trial participants can discontinue at any time; even if you have already agreed to participate and are conducting research, you can stop participating in the study.

1  Even if the respondent has stopped clinical research, the standard treatment will still be available. If you have questions regarding this, you can ask the medical staff at any time.

A consent form is used to provide information about clinical trials to those who are prepared to
participate. After having the clinical study explained to them, the subjects should be able to understand
the following.

1  Purpose of research

1  Course of study

1  Possible profit and risks associated with participation

1  The rights of people to participate in clinical studies

1  Participating in a clinical study is a voluntary choice

1  Other options you can choose after deciding not to participate in clinical trials

1  After explaining the clinical study, the participant may ask the researcher any questions.

1  Participants must clearly understand the study and agree to participate while they are in a stable state, and any external coercive elements are completely excluded

1  You may have plenty of time to consult with your family, friends, or primary care physician (PCP) about potential studies

1  Finally, subjects who agree to participate in the clinical study must sign the agreement. The researcher must subsequently provide the subjects with any new information that is relevant to the research.

Those who wish to participate in clinical studies should be aware of as much information as possible
in relation to the purpose of the research. You may contact a research officer, doctor, research nurse,
or clinical trial committee at any time to discuss the adverse effects of drugs used in clinical studies,
things to be aware of during the test period, and the rights of participants.

1  What is the purpose of this clinical study?

1  Who is eligible to participate in this clinical study?

1  Why do researchers think that this treatment will be effective?

1  Is there sufficient evidence to prove the efficacy of the drug?

1  What kinds of patients are being tested and treated?

1  Compared with the standard treatment, does the investigational drug have any side effects and risks?

1  Will the study impact upon daily life?

1  How long does this clinical study last for?

1  Does the study require hospitalization?

1  Who is responsible for the cost of treatment and what costs does the patient have to pay?

1  How long after this test can patients seek alternative medical care?

1  Will the results of this test be made available?

1  Who is the head of safety and protection?

Institutional Review Board

arrowAn Institutional Review Board (IRB) is a permanent examination committee established independently within a medical institution to protect the rights and safety of clinical trial human subjects.

arrowIt is based on the Law on Life and the Food and Drug Administration (FDA) clinical trial management standards. The IRB stipulates that the committee must include non-scientific members who are not related to the appropriate test bodies, such as lawyers, religionists, and ethics parties.

Considerations for Clinical Trial

1  Clinical studies are conducted in a variety of ways. The research officer must follow the prescribed rules in selecting respondents who will participate in the study. They should be able to participate in research that is appropriate for the nature of the study.

1  If the respondent is eligible for the clinical study, their doctor may ask for their participation.

1  Relevant clinical trials can be identified online.

1  Those who wish to participate in a clinical study must agree and provide fully-informed consent.

1  Clinical trial participants can discontinue at any time; even if you have already agreed to participate and are conducting research, you can stop participating in the study.

1  Even if the respondent has stopped clinical research, the standard treatment will still be available. If you have questions regarding this, you can ask the medical staff at any time.

A consent form is used to provide information about clinical trials to those who are prepared to participate. After having the clinical study explained to them, the subjects should be able to understand the following.

1  Purpose of research

1  Course of study

1  Possible profit and risks associated with participation

1  The rights of people to participate in clinical studies

1  Participating in a clinical study is a voluntary choice

1  Other options you can choose after deciding not to participate in clinical trials

1  After explaining the clinical study, the participant may ask the researcher any questions.

1  Participants must clearly understand the study and agree to participate while they are in a stable state, and any external coercive elements are completely excluded

1  You may have plenty of time to consult with your family, friends, or primary care physician (PCP) about potential studies

1  Finally, subjects who agree to participate in the clinical study must sign the agreement. The researcher must subsequently provide the subjects with any new information that is relevant to the research.

Those who wish to participate in clinical studies should be aware of as much information as possible in relation to the purpose of the research. You may contact a research officer, doctor, research nurse, or clinical trial committee at any time to discuss the adverse effects of drugs used in clinical studies, things to be aware of during the test period, and the rights of participants.

1  What is the purpose of this clinical study?

1  Who is eligible to participate in this clinical study?

1  Why do researchers think that this treatment will be effective?

1  Is there sufficient evidence to prove the efficacy of the drug?

1  What kinds of patients are being tested and treated?

1  Compared with the standard treatment, does the investigational drug have any side effects and risks?

1  Will the study impact upon daily life?

1  How long does this clinical study last for?

1  Does the study require hospitalization?

1  Who is responsible for the cost of treatment and what costs does the patient have to pay?

1 How long after this test can patients seek alternative medical care?

1  Will the results of this test be made available?

1  Who is the head of safety and protection?

Institutional Review Board

arrowAn Institutional Review Board (IRB) is a permanent examination committee established independently within a medical institution to protect the rights and safety of clinical trial human subjects.

arrowIt is based on the Law on Life and the Food and Drug Administration (FDA) clinical trial management standards. The IRB stipulates that the committee must include non-scientific members who are not related to the appropriate test bodies, such as lawyers, religionists, and ethics parties.

Considerations for Clinical Trial

1  Clinical studies are conducted in a variety of ways. The research officer must follow the prescribed rules in selecting respondents who will participate in the study. They should be able to participate in research that is appropriate for the nature of the study.

1  If the respondent is eligible for the clinical study, their doctor may ask for their participation.

1  Relevant clinical trials can be identified online.

1  Those who wish to participate in a clinical study must agree and provide fully-informed consent.

1  Clinical trial participants can discontinue at any time; even if you have already agreed to participate and are conducting research, you can stop participating in the study.

1  Even if the respondent has stopped clinical research, the standard treatment will still be available. If you have questions regarding this, you can ask the medical staff at any time.

A consent form is used to provide information about clinical trials to those who are prepared to participate. After having the clinical study explained to them, the subjects should be able to understand the following.

1  Purpose of research

1  Course of study

1  Possible profit and risks associated with participation

1  The rights of people to participate in clinical studies

1  Participating in a clinical study is a voluntary choice

1  Other options you can choose after deciding not to participate in clinical trials

1  After explaining the clinical study, the participant may ask the researcher any questions.

1  Participants must clearly understand the study and agree to participate while they are in a stable state, and any external coercive elements are completely excluded

1  You may have plenty of time to consult with your family, friends, or primary care physician (PCP) about potential studies

1  Finally, subjects who agree to participate in the clinical study must sign the agreement. The researcher must subsequently provide the subjects with any new information that is relevant to the research.

Those who wish to participate in clinical studies should be aware of as much information as possible in relation to the purpose of the research. You may contact a research officer, doctor, research nurse, or clinical trial committee at any time to discuss the adverse effects of drugs used in clinical studies, things to be aware of during the test period, and the rights of participants.

1  What is the purpose of this clinical study?

1  Who is eligible to participate in this clinical study?

1  Why do researchers think that this treatment will be effective?

1  Is there sufficient evidence to prove the efficacy of the drug?

1  What kinds of patients are being tested and treated?

1  Compared with the standard treatment, does the investigational drug have any side effects and risks?

1  Will the study impact upon daily life?

1  How long does this clinical study last for?

1  Does the study require hospitalization?

1  Who is responsible for the cost of treatment and what costs does the patient have to pay?

1  How long after this test can patients seek alternative medical care?

1  Will the results of this test be made available?

1  Who is the head of safety and protection?

Institutional Review Board

arrowAn Institutional Review Board (IRB) is a permanent examination committee established independently within a medical institution to protect the rights and safety of clinical trial human subjects.

arrowIt is based on the Law on Life and the Food and Drug Administration (FDA) clinical trial management standards. The IRB stipulates that the committee must include non-scientific members who are not related to the appropriate test bodies, such as lawyers, religionists, and ethics parties.

Considerations for Clinical Trial

1  Clinical studies are conducted in a variety of ways. The research officer must follow the prescribed rules in selecting respondents who will participate in the study. They should be able to participate in research that is appropriate for the nature of the study.

1  If the respondent is eligible for the clinical study, their doctor may ask for their participation.

1  Relevant clinical trials can be identified online.

1  Those who wish to participate in a clinical study must agree and provide fully-informed consent.

1  Clinical trial participants can discontinue at any time; even if you have already agreed to participate and are conducting research, you can stop participating in the study.

1  Even if the respondent has stopped clinical research, the standard treatment will still be available. If you have questions regarding this, you can ask the medical staff at any time.

A consent form is used to provide information about clinical trials to those who are prepared to participate. After having the clinical study explained to them, the subjects should be able to understand the following.

1  Purpose of research

1  Course of study

1  Possible profit and risks associated with participation

1  The rights of people to participate in clinical studies

1  Participating in a clinical study is a voluntary choice

1  Other options you can choose after deciding not to participate in clinical trials

1  After explaining the clinical study, the participant may ask the researcher any questions.

1  Participants must clearly understand the study and agree to participate while they are in a stable state, and any external coercive elements are completely excluded

1  You may have plenty of time to consult with your family, friends, or primary care physician (PCP) about potential studies

1  Finally, subjects who agree to participate in the clinical study must sign the agreement. The researcher must subsequently provide the subjects with any new information that is relevant to the research.

Those who wish to participate in clinical studies should be aware of as much information as possible in relation to the purpose of the research. You may contact a research officer, doctor, research nurse, or clinical trial committee at any time to discuss the adverse effects of drugs used in clinical studies, things to be aware of during the test period, and the rights of participants.

1  What is the purpose of this clinical study?

1  Who is eligible to participate in this clinical study?

1  Why do researchers think that this treatment will be effective?

1  Is there sufficient evidence to prove the efficacy of the drug?

1  What kinds of patients are being tested and treated?

1  Compared with the standard treatment, does the investigational drug have any side effects and risks?

1  Will the study impact upon daily life?

1  How long does this clinical study last for?

1  Does the study require hospitalization?

1  Who is responsible for the cost of treatment and what costs does the patient have to pay?

1  How long after this test can patients seek alternative medical care?

1  Will the results of this test be made available?

1  Who is the head of safety and protection?

Institutional Review Board

arrowAn Institutional Review Board (IRB) is a permanent examination committee established independently within a medical institution to protect the rights and safety of clinical trial human subjects.

arrowIt is based on the Law on Life and the Food and Drug Administration (FDA) clinical trial management standards. The IRB stipulates that the committee must include non-scientific members who are not related to the appropriate test bodies, such as lawyers, religionists, and ethics parties.