Experimental Studies and Clinical Trials

Question 1

clinical trial

Answer 1

evaluates the efficacy and safety of a new drug or medical procedure

Question 2

phase 1 trial

Answer 2

unblinded
uncontrolled
< 30 participants
used to determine safety and potential of a drug/device in humans

Question 3

phase 2 trial

Answer 3

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

Question 4

experimental study

Answer 4

researchers evaluate the effects of an assigned intervention on an outcome

Question 5

prohylactic trial

Answer 5

evaluates preventative measures

Question 6

therapeutic trial

Answer 6

assesses new treatment methods likely to benefit the participants in some way (experimental drug - drug trial).

Question 7

community trial

Answer 7

tests a group intervention designed for the purpose of educational and behavioral changes at the population level

Question 8

random assignment

Answer 8

group assignment is determined by chance

Question 9

randomized control trials are

Answer 9

the most common type of trial

Question 10

blinding

Answer 10

minimizes potential bias from the placebo effect

Question 11

placebo

Answer 11

a substance containing no medication or a false treatment that is given to satisfy a patient’s expectations

Question 12

What is a placebo good for when given to the control group in experimental studies?

Answer 12

provides a comparitive basis for determining the effect of the treatment being investigated

Question 13

the placebo effect

Answer 13

the effect on a patient’s outcomes that may occur because of the certain expectation

Question 14

blinding patients in controlled trials does what?

Answer 14

minimizes placebo effect

Question 15

the FDA recommended in the 1970s that new drug trials be

Answer 15

double blind

Question 16

single-blind

Answer 16

participants are unaware of who is receiving the active treatment but investigators know

Question 17

double-blind

Answer 17

neither particiapnts or investigators know who is recieving the active treatment

Question 18

triple-blind

Answer 18

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

Question 19

placebos are best used for ___?

Answer 19

drug studies as patients will think they are benefiting from a given medication

Question 20

phase 3 trial

Answer 20

random assignment
thousands of participants
evaluate the efficacy of a new treatment and different dosage or methods of administration of the treatment

Question 21

phase 4 trial

Answer 21

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

Question 22

behavioral interventions

Answer 22

begin with identified problem, are often developed from behavior theory, and refined with focus groups