Experimental Studies and Clinical Trials Flashcards
clinical trial
evaluates the efficacy and safety of a new drug or medical procedure
phase 1 trial
unblinded
uncontrolled
< 30 participants
used to determine safety and potential of a drug/device in humans
phase 2 trial
possible random assignment
possible blinding
25 to 100 participants
treated at phase 1 levels
participants receive different doses/treatment
used to identify the type of disease the tx is effective against, safe dosage levels, and side effects
if evidence shows efficacy in treatment, phase 3 is warranted
experimental study
researchers evaluate the effects of an assigned intervention on an outcome
prohylactic trial
evaluates preventative measures
therapeutic trial
assesses new treatment methods likely to benefit the participants in some way (experimental drug - drug trial).
community trial
tests a group intervention designed for the purpose of educational and behavioral changes at the population level
random assignment
group assignment is determined by chance
randomized control trials are
the most common type of trial
blinding
minimizes potential bias from the placebo effect
placebo
a substance containing no medication or a false treatment that is given to satisfy a patient’s expectations
What is a placebo good for when given to the control group in experimental studies?
provides a comparitive basis for determining the effect of the treatment being investigated
the placebo effect
the effect on a patient’s outcomes that may occur because of the certain expectation
blinding patients in controlled trials does what?
minimizes placebo effect
the FDA recommended in the 1970s that new drug trials be
double blind
single-blind
participants are unaware of who is receiving the active treatment but investigators know
double-blind
neither particiapnts or investigators know who is recieving the active treatment
triple-blind
participants and investigators do not know who is recieving active treatment plus those who analyze the data are kept from knowing the nature of the interventions
placebos are best used for ___?
drug studies as patients will think they are benefiting from a given medication
phase 3 trial
random assignment
thousands of participants
evaluate the efficacy of a new treatment and different dosage or methods of administration of the treatment
phase 4 trial
possible random assignment
large study
conducted after the therapy has been approved by the FDA to assess the rate of serious side-effects and therapeutic issues
behavioral interventions
begin with identified problem, are often developed from behavior theory, and refined with focus groups
