3.8- clinical trials of vaccines and drugs

Question 1

why must vaccines undergo clinical trials on humans?

Answer 1

to establish they are safe and effective

Question 2

what do treatments undergo before a clinical trial?

Answer 2

extensive testing on cells and animals in the laboratory

Question 3

what happens in phase 3 of a clinical trial?

Answer 3

split into test group that receive the treatment and control group who will not

Question 4

3 rules of protocol at stage 3

Answer 4

placebo controlled

double blind

randomised

Question 5

what are members of the control group given and why?

Answer 5

placebo

to assess the placebo effect

Question 6

function of the placebo

Answer 6

allows for a valid comparison to be made between the test group and the control group to assess the effect of the new treatment

Question 7

what is a blind trial?

Answer 7

human subjects do not know whether they are receiving the active treatment or the placebo

Question 8

what is a double blind trial?

Answer 8

neither the subject nor the doctors know who is receiving what

Question 9

why is a double blind trial used at phase 3?

Answer 9

to eliminate bias

Question 10

why are subjects divided in a randomised way at stage 3?

Answer 10

reduce bias in the distribution of characteristics such as age and gender

Question 11

what could potentially invalidate the results?

Answer 11

if one group received more older subjects who were more seriously ill

Question 12

2 ways experimental error is reduced

Answer 12

distribution of subjects through a computer

very large sample population

Question 13

why must a very large population be used at phase 3?

Answer 13

so results can be subjected to statistical analysis

results from 2 groups can then be compared to find out if significant differences exist between them that indicate the new treatment is effective