A Comprehensive Look at Clinical Trials
Glossary of TermsDouble-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.
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 a patient to participate in a trial. The patient 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 the treatment that is assigned.
Phase I Trial: The first stage in testing a new drug in humans. The studies are usually done to gather preliminary information on the chemical action, dosage and safety of the drug using healthy volunteers. Usually done without a comparison group.
Phase II Trial: The second stage in testing a new drug in humans. Performed in patients with the disease or condition being studied. The main purpose is to evaluate the activity of a drug, and to possibly provide information on how well the drug works.
Phase III Trial: The third and usually final stage in testing a new drug in humans. Used to collect information about the safety of a drug and how well it works. Once this phase is complete, the drug manufacturers may request permission from the Food and Drug Administration to market the drug.
Side Effects: The action or effect of a drug 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)
This article was provided by AIDS Community Research Initiative of America. Visit ACRIA's website to find out more about their activities, publications and services.