A glossary of terms used in research studies.

Adverse Reactions
Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

Clinical Trial
A carefully designed investigation of the effects of drug, medical treatment, or device on a group of patients.

Clinical Investigator
A medical researcher in charge of carrying out a clinical trial's protocol. Researchers are usually doctors, nurses, pharmacists, or other health care professionals.

Control or Control Group
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

Food and Drug Administration (FDA)
A government agency that enforces laws on the manufacture, testing, and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be used by the general public.

Informed Consent
Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include:

• Why the research is being done
• What the researchers want to accomplish
• What will be done during the trial and for how long
• What risks are involved in the trial
• What benefits can be expected from the trial
• What other treatments are available
• The fact that you have the right to leave the trial at any time

Institutional Reveiw Board (IRB)
A board consisting of health care professionals from the institution where the clinical trial takes place, as well as members of the local community. The board scrutinizes all trial activities including recruitment, advertising, and potential risks. The IRB also makes sure that FDA regulations are being followed in a particular trial.

Investigational Treatment
The drug or medical device that is tested during a clinical trial.

Phases
Drugs and medical devices must pass three segments or phases of testing before they can be eligible for FDA approval.

• In Phase I clinical trials, researchers test a new drug or treatment in a small group of people to evaluate its safety, determine a safe dosage range, and identify side effects.
• In Phase II clinical trials, the study drug or treatment is given to a larger group of people to see if it is effective and to further evaluate safety.
• In Phase III studies, the study drug or treatment is given to large groups of people to confirm effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.

Placebo
A placebo is an inactive pill, liquid, or powder that has not treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.

Principal Investigator
A medical professional who is overseeing the treatment of the patients in the clinical trial.

Protocol
A plan that sets guidelines for a trial and usually involves several different trial locations. The protocol is usually designed by the sponsor of a clinical trial.

Sponsor
The pharmaceutical company, research institution, or other health organization that funds a clinical trial and designs its protocol.

Standard treatment
An FDA-approved treatment currently in wide use. In trials involving new treatments, there may be no pre-existing treatment. In these cases, the lack of any treatment is considered the standard treatment. Generally, the goal of a clinical trial is to introduce an investigational treatment that is safer and more effective than standard treatment.

Study Coordinator
This individual works closely with the Principal Investigator to manage the conduct of the clinical trial.