Clinical Trials Terminology
Blinded: To make certain that a clinical trial produces good results, both the investigator and the patient/volunteer are "blinded"; therefore, they will not know which treatment the patient is getting until the study is over.
Clinical investigator: Usually a doctor, this is the individual who directs the clinical trial and is responsible for directing your study.
Clinical research coordinator: A nurse or other healthcare professional who assists the principal investigator in conducting the trial.
Clinical trial:A scientific study that tests the effectiveness of a new medical treatment, drug or device in patients and volunteers.
Informed consent: This refers to the complete and open discussion of a clinical trial between the investigator(s) or research team member(s) and the patient/volunteer, during which all benefits, risks, procedures and expectations are explained. The FDA requires that this must occur before a patient/volunteer signs an informed consent form agreeing to participate in the trial.
Institutional Review Board for Health Sciences Research (IRB-HSR), previously known as the Human Investigations Committee (HIC): A committee of healthcare professionals and local citizens that monitors all clinical research trials being conducted in an institution. Protecting the safety and rights of participants is the primary purpose of this group.
Open label study: A trial in which treatment is known to both the subject and investigator(s).
Placebo: An inactive form of treatment that has no effect, sometimes called a "sugar pill."
Research assistant: A nurse or other healthcare professional who assists the clinical investigator(s) and coordinator(s) in running a trial.
Sponsor: Usually a pharmaceutical, drug or medical device company that wishes to investigate the effectiveness of a new product and financially supports the investigation.
Standard treatment: Any treatment for a disease or condition that is currently in wide use and approved by the FDA. Clinical trials compare a new treatment to the standard treatment. If no prior treatment exists, a clinical trial will regard the lack of any treatment as the standard treatment.
Subject: The patient/volunteer who participates in a trial.
U.S. Food and Drug Administration (FDA): The government agency that sets guidelines on the testing, manufacture and use of new medical drugs, treatments or devices before they can be used by the general public.