About Clinical Research - ARGENX 2682-0011
What is a Clinical Research Study?
Before a drug or treatment can be approved for use, there must be proof that the investigational drug works and is considered safe enough for the tested population. Clinical research studies, also called clinical trials, look for new ways to prevent, detect, and treat disease. They are designed to test the safety and effectiveness of investigational study drugs to understand if these potential treatments can be used in the future.
Clinical studies used in drug development are sometimes described by phases. Each phase has a different purpose and helps researchers answer different questions.
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Researchers test an investigational drug in a small group of healthy people to determine how much of the study drug is safe to take and how the human body reacts when it receives the drug. |
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Researchers look at which dose of the investigational study drug works best in a larger group of people who have the disease that is being studied. The purpose of this phase is to further evaluate the safety and the effectiveness of the investigational study drug. |
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Researchers look at which dose of the investigational study drug works best in an even larger group of people than the phase two study for a longer period of time. The investigational study drug is given to large groups of people with the disease being studied to measure its effectiveness and side effects, compare it with the standard of care or similar treatments, and collect information that will allow the new drug or treatment to be used safely. |
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At this point the investigational study drug is now approved for use. In this phase researchers are tracking the safety of the approved drug in the general population, seeking more information about a drug or treatment’s benefits, and optimal use. |
What is a Clinical Research Study?
Before a drug or treatment can be approved for use, there must be proof that the investigational drug works and is considered safe enough for the tested population. Clinical research studies, also called clinical trials, look for new ways to prevent, detect, and treat disease. They are designed to test the safety and effectiveness of investigational study drugs to understand if these potential treatments can be used in the future.
Clinical studies used in drug development are sometimes described by phases. Each phase has a different purpose and helps researchers answer different questions
![]() |
Researchers test an investigational drug in a small group of healthy people to determine how much of the study drug is safe to take and how the human body reacts when it receives the drug. |
![]() |
Researchers look at which dose of the investigational study drug works best in a larger group of people who have the disease that is being studied. The purpose of this phase is to further evaluate the safety and the effectiveness of the investigational study drug. |
![]() |
Researchers look at which dose of the investigational study drug works best in an even larger group of people than the phase two study for a longer period of time. The investigational study drug is given to large groups of people with the disease being studied to measure its effectiveness and side effects, compare it with the standard of care or similar treatments, and collect information that will allow the new drug or treatment to be used safely. |
![]() |
At this point the investigational study drug is now approved for use. In this phase researchers are tracking the safety of the approved drug in the general population, seeking more information about a drug or treatment’s benefits, and optimal use. |
More Information About Clinical Trials
To help ensure that a research study is ethical and that patients' rights are protected, Institutional Review Boards (IRB), Ethics Committees (EC) or Ministry of Healths (MOH) review and approve study protocols that detail all aspects of how the study is conducted. There are also teams that monitor the study called Clinical Research Associates; they visit the study sites to make sure the study protocol procedures, research requirements and country regulations are being followed throughout the study. Health authorities may also inspect the study sites to ensure the safety and rights of the subjects participating in a trial and the integrity of the research study objectives.
Participants who meet all required criteria for a clinical trial may take part. The study team at the clinic will review the participant’s medical history and current medical status to make sure he or she is a good fit to participate in the study.
An investigational drug is a product that has not been approved by a country’s regulatory authorities (eg, the U.S. Food and Drug Administration) for medical use.