Clinical Trials Glossary
A blind clinical trial is one where the participants are not told which treatment they are receiving.
A clinical trial is a scientific and medical trial using human subjects to test the safety and efficacy of new drugs or medical treatments.
In clinical trials the control group is given a different medication than the test group in order to compare the results of the two.
A double blind clinical trial is one where both the participants and the administrators of the trial do not know which group of participants is receiving which treatment.
Dose Ranging Study
Clinical trial where different doses of drugs are given to different groups of participants to determine which dose is most beneficial.
Efficacy is the ability to produce results. In clinical trials it means the ability of the drug being tested to prove an effective treatment.
Criteria that will make a potential participant ineligible to participate in a clinical trial. This might include age, weight, overall health, extent of the disease, and former treatments received.
FDA (Food and Drug Administration)
The FDA is the division of the U.S. Department of Health and Human Services that is responsible for the safety of drugs and medication marketed to the public. The FDA must approve drugs before they are sold to the public.
Inclusion criteria are the criteria that participants must meet in order to qualify for participation in a clinical trial. This might include age, weight, overall health, extent of the disease, and former treatments received.
Informed consent is the right of clinical trials participants to be made aware of all aspects of what they can expect during the clinical study. This includes treatments, time and travel commitments and potential risks. Participants must sign a document confirming their consent.
Institutional Review Board
An institutional review board is made up of physicians, medical personnel, community advocates, and others. It is their job to ensure that participants in clinical trials are safe and being treated ethically.
Off-label use occurs when a drug is prescribed for something other than what the FDA approved.
Phase I Clinical Trials
Phase I clinical trials are initial studies using a small test group to see if a drug is safe for use in humans.
Phase II Clinical Trials
Phase II clinical trials are secondary studies that evaluate the effectiveness of drugs and their side effects on humans. They often study whether the new drug is better than current treatments.
Phase III Clinical Trials
Phase III clinical trials are expanded clinical trials usually involving a large number of participants often across many facilities or locations. Phase III testing looks at the benefit/risk relationship of new medications.
Phase IV Clinical Trials
Phase IV clinical trials are when drugs that have been approved for sale to the general public, either over the counter or by prescription, are continually studied in a larger population.
A placebo is an ineffective treatment given in clinical trials to compare to a new medication.
The placebo effect describes physical or emotional changes a clinical trial participant experiences based on their expectations, and not because they have been given a new medication.
Preclinical testing is testing done prior to clinical trials and prior to any testing on humans. It usually involves research and testing on animals or cells.
Randomized clinical trials are when two groups of participants are chosen at random to receive different treatments so that the effects of each can be compared.
Recruiting refers to the phase of a clinical trial where participants are screened for eligibility.
Side effects are unwanted, often negative results of taking a medication.