Glossary of Terms

Double-Blind - A procedure for assigning treatment regimens which keeps both trial participants and members of the research staff from knowing which participants are on which assigned treatments.

Efficacy - The ability of a drug, procedure or therapy to control or cure a diagnosed disorder or illness.

Institutional Review Board (IRB) - A committee of physicians, statisticians, community advocates, and others which ensures that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials in the United States must be approved by an IRB before they begin.

Informed Consent - The voluntary consent given by an individual to participate in a trial. The participant must be informed of the trial’s purpose, treatment, benefits and risks of participation, and the schedule of required procedures.

Open Label Trial - A trial in which the research staff and the trial participant know to which treatment the participant has been assigned.

Placebo - An inactive agent given as a substitute for an active agent for the purpose of comparison.

Randomization - The process of assigning patients to different treatments by chance.

Side Effects - The action or effect of a drug or therapy beyond what it is supposed to do. The term usually refers to undesired or negative effects, such as headache, skin irritation, or liver damage. Side effects can be expected or unexpected, desired or undesired. Experimental drugs must be evaluated for both immediate and long-term side effects.

Adapted from Glossary of Medical, Statistical, and Clinical Research Terminology by Carlton Hogan, University of Minnesota, for the National AIDS Treatment Advocates Forum (NATAF)