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.

 

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