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Clinical Trials Glossary
by Dawn Averitt
Clinical trial: A study of a medicine or disease in people.
Data: The information collected by researchers during a study to help better understand the study topic.
Dose-escalating: A dose-escalating study is usually an early study done to figure out how much of a medicine should be given to an individual. Dose-escalating means gradually increasing the amount of medicine until the correct amount is determined.
Double-blind or blinded: A blinded study is designed so that the participant does not know which treatment arm they are on. A double-blind study is one where neither the doctor nor the participant know which treatment arm the participant is taking. Exclusion criteria: Factors that will prevent a person from participating in a specific study either for their safety or to make it easier to understand the study results. For example, someone might be excluded for having liver problems, or if they’ve already used a drug that is being studied.
Observational study: A study that observes participants and collects information about their medical history, but does not assign treatments or interfere with their health care.
Open-label: A study in which the participants know which treatment arms and medications they are on.
Placebo: A sugar pill that looks like the drug being studied, but does not contain medicine.
Protocol: A scientific plan that describes the reason for doing a study, how it will be done, and what the goals of the study are.
Placebo-controlled: A study that gives some people a placebo and some people a medicine so that the effect of the medicine can be compared to no treatment.
Randomized: Assigned by chance or randomly. This refers to the way people are assigned to different arms of a study.
Study arm: An arm of a study is a specific treatment being studied and involves a group of people usually being compared to another group, or arm, of the study.
Treatment-experienced: A person who has already taken at least one anti-retroviral medicine to treat their HIV disease. Treatment-naïve: A person who has never taken anti-retroviral medicines to treat their HIV disease.
Inclusion criteria: Requirements that a participant must meet to participate in a specific study (such as T-cell count, viral load, age, or other laboratory values).
Reprinted courtesy of www.PositiveWords.com. |
