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Clinical Research Glossary
Adverse reactions (or side effects) - An adverse event or side effect is an unwanted effect (such as a physical problem like skin irritation or headache) caused by the administration of a treatment. Onset may be sudden or develop over time. Experimental treatments must be evaluated for both immediate and long-term side effects.
Clinical trial - A clinical trial is a medical research study to answer specific questions about new treatments or new ways of using known treatments. Clinical trials (also called medical research, clinical research, and research studies) are used to determine whether new drugs or treatments are safe and effective. The studies are performed under very strict guidelines and are the fastest and safest way to find treatments that work in people. There are four different "phases" of clinical trials: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed (approved for use in the United States by the Food and Drug Adminstration) and marketed.
Controlled study - In many clinical trials, one group of patients will be given an experimental treatment, while the "control" group is given either a standard treatment or a "placebo". Researchers are usually looking at how one treatment stacks up against another or even against no treatment at all. To make the comparison useful, the investigator must try both methods on similar groups of subjects. Researchers call the treatment with the predictable, or known effect, the control. The control may be a standard, commonly used treatment, or it may be a placebo. A placebo is an inactive pill, liquid, powder, or other modality with no treatment value (commonly referred to as a "sugar pill"). Some studies use both a standard treatment and a placebo as controls. The control helps an investigator find out if any changes in the experimental group are, in fact, due to the new treatment.
Double-blind/single-blind study - In some studies, the patient does not know whether he or she is in the treatment or control group (a single-blind study); in others, neither the patient nor the researcher know (a double-blind study). This is a way of avoiding bias in the results. Sometimes when people know what treatment they are getting, it changes the way they react; similarly, the researchers' own expectations about the treatment could influence how they perceive patients' reactions, side effects, and progress during the study. Participants in clinical trials are randomly assigned to treatment groups once they've been accepted into the study and have agreed to participate by signing an informed consent.
Exclusion/inclusion criteria - These criteria are the standards determining whether a person may or may not be allowed to enter a clinical trial. The criteria are based on such factors as age, gender, the type and stage of a condition, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.
Informed consent - The informed consent is both a process and a physical form. The process involves learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. In order to participate in the study, patients are asked to sign an "informed consent" form which indicates that they've learned about the study's risks, benefits, and process and that they understand it and are consenting to participate fully.
Institutional Review Board (IRB) - The IRB is a committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. Every U.S. institution that conducts or supports biomedical or behavioral research involving human participants must, by U.S. federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants.
Phase I trials - In Phase I, a trial tests a potential new treatment with a small number of volunteers (20-80 individuals) to determine the treatment's safety and potential side effects. Participants in Phase I trials may include patients and "healthy" participants.
Phase II trials - Phase II studies test a treatment with known dose and side effects with a larger number of volunteers to learn more about side effects, how the body responds to the treatment, and whether the treatment is effective in treating the condition.
Phase III trials - In Phase III, the new treatment is compared with commonly used treatments and monitored for long-term side effects.
Phase IV trials - Phase IV trials are conducted after a treatment is on the market and help to provide additional information about the treatment's risks, benefits, and best use.
Placebo or "sugar pill" - A placebo is an inactive pill, liquid, powder, or other modality with no treatment value (commonly referred to as a "sugar pill"). Some studies use both a standard treatment and a placebo as controls. The control helps an investigator find out if any changes in the experimental group are, in fact, due to the new treatment.
Randomized study - A study in which participants are randomly (i.e., by chance) assigned to one of two or more parts of a clinical trial. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial segments. The researchers do not know which treatment being studied is better. Or, if a placebo is being used, the researchers don't know if the treatment being studied will have any effect, or not. Randomization keeps the study's results from being affected by human choices or other factors not related to the treatments being tested.
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