About Clinical Trials
What is a clinical research study?
Before any medication can be approved for an illness, by law it must be proven to be safe and effective in research studies. These are also called clinical trials, clinical studies, or clinical research studies.

Even after a medicine is “approved” for doctors to prescribe, clinical research studies can continue to be conducted to increase understanding about how a particular medicine can be most effectively used by doctors. The medicine being investigated in a clinical research study is called an “investigational medicine.”

Without clinical trials, new medications cannot be developed.

Why do people participate in clinical research studies?
People participate in clinical research studies for various reasons including:
  • Gaining access to new medical treatments not yet widely available
  • Helping researchers understand if and how an investigational drug works
  • Allowing future generations to potentially benefit from new treatments

What are the different phases of clinical research trials?
Clinical research trials are traditionally divided into different phases. Each phase is designed to gather specific information about the study drug or treatment.

Phase I studies
The first human tests of investigational medicines or therapies occur in Phase I studies. Phase I clinical research studies are designed to determine the best dose of the study medicine and to check for any potential side effects. These studies usually involve small numbers of participants. Phase I studies use study medicines that have never been tested in humans; because of this they may involve significant risks.

Phase II studies
If an investigational medicine is initially shown to be safe and well tolerated, it moves on to Phase II studies. These studies are designed to see how well the study medicine works, usually in a larger group of participants.

Phase III studies
If the investigational medicine is shown to be effective in Phase II studies, it may move on to Phase III studies. Phase III studies evaluate the safety and how well the medicine works in hundreds, or even many thousands of participants. Often Phase III studies compare the study medicine to an existing standard treatment or placebo in a randomized fashion.

The EXPEDITION Study is a phase III study.

Phase IV studies
These studies are conducted after a medicine has been approved to be used by doctors by the regulatory bodies. In the US this is the Food and Drug Association (FDA) and in Europe this is European Medicines Agency (EMEA). Phase IV studies typically involve a large number of participants. They may evaluate new uses of existing medicines or be used to detect side effects that did not appear during Phase III studies.
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