Glossary of Clinical Trial Terms
Control group: The arm of a randomized trial which gets standard treatment (if there is an effective treatment available) plus or minus a placebo. In some randomized trials, both of the treatments are standard treatments, or both equally well known new treatments, and in such cases it is not appropriate to speak of a control group.
Eligibility criteria: Characteristics about the people researchers would like to study in a clinical trial. These characteristics generally include age, the type and stage of cancer, any previous treatments, and other medical conditions the person may have.
Food and Drug Administration: The United States Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines and medical devices.
Informed consent: A written document, signed by the clinical trial participant, that states he or she has given permission freely without being pressured to enter the trial, with full knowledge and understanding of what is involved.
Institutional Review Board (IRB): A committee comprised of community members, spiritual care, patients and medical personnel that assures appropriate steps are taken to protect the rights and welfare of participants as subjects in research trials. The IRB is responsible to review and approve the protocols for all clinical trials to ensure protection in accordance with the Food and Drug Administration guidelines.
Placebo: An inactive substance such as a “sugar pill” that may be given to control group participants in a clinical trial. A myth about randomized cancer clinical trials is that the patients in the control group always get just a placebo. The truth is that whenever there is a standard treatment the investigators think may be effective, the control group will at least get that treatment.
Principal investigator: The lead researcher (physician) in a clinical trial.
Randomization: In a clinical trial, the random assignment of participants by computer to the different groups of people in the study: for example, those who will receive a new treatment and those who will receive standard treatment.
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