Module 1 Flashcards
clinical trial definition
a clinical trial is a research study involving human participants that evaluates the safety/and or effects of one or more interventions on health conditions
intervention
usually (but not always) concerned with the
evaluation of drug therapy
control group
group of subjects against which the intervention group is compared. Usually the best standard current therapy. No active treatment means a placebo or no treatment at all
four questions (to determine if it is a clinical trial)
- Does the study involve human participants?
- Are the participants prospectively assigned to an
intervention? - Is the study designed to evaluate the effect of the
intervention on the participants? - Is the effect being evaluated a health-related
biomedical or behavioral outcome?
treatment trials
test experimental treatments, new combinations of drugs, or new approaches to surgery or
radiation therapy
prevention trials
look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes
diagnostic trials
to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or condition being studies
screening (early detection) trials
test the best way to detect
certain diseases or health conditions
quality of life trials
explore ways to improve conform and
the quality of life for individuals with a chronic illness