AIDS Community Research Initiative of America
A Comprehensive Look at Clinical Trials
By Anne Monroe
2000
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.
Expanded Access: A method of distributing experimental drugs to patients who are unable to participate in clinical trials and have no other treatment options.
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 II/III Trial: A special classification for a trial that speeds up the process by combining two phases.
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.
Phase IV Trial: A large trial designed to evaluate the long-term safety and effectiveness of a drug that has been approved by the Food and Drug Administration.
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 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.
