Immunology and Neurobiology Unit 3 KA 8

Question 1

Why are Clinical Trials on vaccines and drugs important?

Answer 1

Clinical trials are used to establish the safety and effectiveness of vaccines and drugs before they are licenced for use

Question 2

What do Clinical Trials involve before human trials?

Answer 2

Before human trials begin, clinical trials involve testing on cells and animals

Question 3

What must be included in the design of Clinical Trials? (3)

Answer 3

1) Randomisation
2) Double blind procedure
3) Placebo-controlled prodecures

Question 4

What is the Placebo Effect?

Answer 4

The Placebo Effect is when a control group are given a ‘sham’ treatment to see if it improves their condition due to the psychological effect of thinking it works

Question 5

What is a Double-blind Trial?

Answer 5

A Double-blind Trial is when neither the subjects or the researchers know who is receiving what to eliminate bias

Question 6

Why are clinical trials Randomised?

Answer 6

Clinical trials are Randomised so that the individuals information is hidden and groups are made randomly without bias, not based on their current health/gender/ethnicity/age

Question 7

Why must sample group size be suitable?

Answer 7

Sample group size must be suitable to reduce the magnitude of the experimental error

Question 8

What happens at the end of the Clinical trials?

Answer 8

At the end of the Clinical trials, the trial results are compared to determine whether there are any statistically significant differences between the groups

Question 9

What must take place before a new ?Clinical trial can begin? (4)

Answer 9

1) Science/research must be reviewed
2) Researchers must secure funding
3) Home base is needed for trial
4) MHRA must approve trial
5) Ethics commitee must review and approve trial