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When you read about clinical research studies, you will see words that are probably unfamiliar. Some of the more common terms are described in this pamphlet. If there are words that you do not understand, ask someone working on the study to explain them to you. You have the right to have everything described to you in a way that you can understand. Do not stop asking questions until you have your explanation.
RANDOMIZATION
The process of assigning a subject to one of the groups on the study. When a study is “randomized”, it means this assignment is done by a method similar to flipping a coin. In other words, neither you nor your doctor get to choose what group you will be in.
PLACEBO
A placebo is an inactive pill. Placebos are most frequently used when there is no standard treatment for a particular disease or when comparing to the standard treatment is not appropriate. The placebo will look just like the pill that contains the investigational drug. A placebo is used to make sure the results are caused by the investigational drug and not by a “placebo effect”. A placebo effect is when people feel better even if they are just taking an inactive pill.
INFORMED CONSENT FORM
The informed consent form is a document that contains many details about the study. It should tell you why the study is being done, what the benefits are, what the risks are, what the alternatives are, what you will have to do while you are in the study, the groups in the study, and many other important details. Be sure someone working on the study reviews this form with you. Take your time and read it. This form is your best source for all of the details about the study. Make sure you understand it completely before you agree to be in the study.
DOUBLE-BLIND
When a study is double-blind, neither the subject, the doctor, nor the study staff know to what group the subject has been assigned. This is another way to prevent biased results.
WHAT IS THE DIFFERENCE BETWEEN A PATIENT AND A SUBJECT?
A person in a clinical research study is called a “subject” to show that there is a difference between a “subject” and a “patient”. A “patient” is treated with approved medications that have been proven to work for their disease or condition. A “subject” is not being “treated”, because the investigational drug they are taking has not been proven to work.
WHERE CAN I GET MORE INFORMATION?
A few websites with more information about clinical research are listed below.
www.centerwatch.com
www.clinicaltrials.gov
http://nccam.nih.gov/clinicaltrials/
http://www.hopkinsclinicaltrials.com/faq.html
http://www.cancer.gov/clinicaltrials
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