There are dozens of terms used by researchers and patient participants in clinical trials. Listed below are some of the more common terms. If you don't find what you are looking for, there are links at the bottom of this page to longer lists of clinical trial terminology.
Bias:
Bias indicates the possibility that the researchers (investigators) may not be totally objective in the way they review the results of the trial. This can happen when the group doing the investigating has a financial stake in the outcome of the trial.Blind Study:
A study in which there is a control group that does not know it is not receiving the tested drug or treatment. They may be receiving nothing at all, or a placebo. See also, "double blind."Cohort:
A cohort is a group that has similar characteristics. For example, all members of a cohort may be the same gender; age; race; have a similar genetic makeup, diagnosis or other attributes that are the same.Control Group:
The control group does not receive the treatment being studied in a treatment trial. Sometimes they know they are the control group and are not receiving the treatment. Other times they may be "blind" (see above) and are given a
placebo to make them think they are getting the treatment even though they are not.
Some control groups are given an already accepted, standard treatment in place of the new one being studied.
Double Blind Study:
In a double blind treatment study, neither the control group nor the investigators know who is getting which treatment. A double blind study is considered to be the most objective way of making sure the results will be nonbiased. Double blind studies are also called "double masked" studies.Experimental Drug:
An experimental drug is any drug that has not been licensed for use in the United States by the FDA.Investigators:
Investigators are the people conducting a clinical trial. They are researchers and may be doctors, scientists or others involved in using the scientific method for drawing conclusions about a drug, device, therapy or other treatment.Placebo:
A fake or false version of whatever drug or therapy is being studied is called a "placebo." It is often made of sugar or another inert ingredient. It is given to the control group of patients to measure against the patients who are taking the real drug or therapy being tested. (Additional information about
placebo.)
Protocol:
The protocol is the plan for the study. All clinical trials must have a thorough, approved protocol before they begin recruiting patients or conducting their tests. The plan includes a list of the questions being asked, the expected outcomes, the profile of the participants, the schedule of tests of procedures, the length of the study and more. Following the protocol is expected to keep the participants safe throughout the study.Randomized:
Once the group of participants has been selected, they are assigned randomly to be a part of either the group receiving the tested treatment or the control group. This random assignment creates a randomized trial.Learn More About Clinical Trials:
