"________-ins" are individuals in randomized trials who inadvertently take the agent (or drug) assigned to the other study group.
The type of study design in which a case serves as their own control is called a case-__________ study.
Because randomized trials usually study volunteers, their external validity tends to be _______ than that of observational studies.
As the US Food and Drug Administration follows a standard sequence of four phases for testing and evaluating new pharmacologic agents, Phase IV studies are called postmarketing surveillance, because this Phase IV studies investigate side effects of a new treatment _______ the drug has been marketed.
The process of selecting the controls so that they are similar to the cases in certain characteristics, such as age and, in our example in class, estrogen usage.
True or False: Interestingly, symptoms of schistosomiasis are not caused by the worms themselves but by the host's reaction to the eggs.
A factorial study design is a useful study design to use when the modes of action of two drugs are different and the anticipated outcomes for the two drugs are ____________.
The Framingham Study (of cardiovascular disease) that began in 1948 is a(an) _____________ cohort study.
True or false: A benefit of randomization is that the likelihood that the groups will be comparable is _____________.
____________ occurs in a clinical trial if there is inadequate time in the "washout period" to assure that first treatment (or therapy) has remained before the second treatment (or therapy) is started.
The intermediate hosts for Schistosoma are freshwater ____________.
True or false: Within the four phase sequence of testing by the U.S. Food and Drug Administration to evaluate new agents (drugs), Phase IV studies are large, randomized trials to investigate the safety and potential side effects of the new treatment.
Within the four phase sequence of testing by the U.S. ______ to evaluate new agents (drugs), Phase IV studies are large, randomized trials to investigate the safety and potential side effects of the new treatment.
The only difference between the designs for the prospective and retrospective or historical cohort study is ______________ time.
Schistosoma ________ are shed by the definitive host in the feces or urine (depending on the species of Schistosoma infecting the host).
A problem that arises in an ecologic study if we ascribe "to members of a group some characteristic that they in fact do not possess as an individuals" is called ecologic ________________. " (pg. 151)
Stratified randomization occurs _____________ the intervention in a clinical trial.
When compared with other types of epidemiologic studies, a nested case-control study minimizes possible selection and recall ________.