U.3 K.A-8 Clinical Trials of Vaccines and Drugs

Question 1

What must vaccines and pharmaceutical drugs go through to establish that they are safe and effective before being licensed for use?

Answer 1

Clinical trials

Question 2

What happens before a clinical trial begins?

Answer 2

Extensive testing on cells and animals in a laboratory

Question 3

How many phases are there in a clinical trial?

Answer 3

3

Question 4

During phase 1 of a clinical trial, how many volunteers are tested with a very small dose of the treatment?

Answer 4

25-30

Question 5

If phase 1 of a clinical trial is successful, phase 2 will proceed. How many people who have the illness will be tested?

Answer 5

150-300

Question 6

What is the purpose of a phase 2 trial?

Answer 6

To test if the treatment is safe and effective and find out the optimum dose

Question 7

During phase 3 of a clinical trial how many people who have the illness are tested?

Answer 7

1000-2000

Question 8

What happened after phase 3 if it is successful?

Answer 8

A licence to manufacture the treatment is sought

Question 9

During phase 3 of a clinical trial people who have the illness are split into what two groups?

Answer 9

A test group and control group

Question 10

During a clinical trial which group out of the test group and the control group will receive the treatment?

Answer 10

Test group

Question 11

What are the members of the control group given during a phase 3 clinical trial?

Answer 11

A placebo

Question 12

What is a placebo?

Answer 12

A sham treatment that lacks the active ingredient being tested

Question 13

What is the placebo effect?

Answer 13

Where patients show an improvement in their condition psychologically as they think they have received the real treatment because of the attention they’ve had from health care staff

Question 14

What does the use of a placebo allow during phase 3 clinical trial?

Answer 14

A valid comparison to be made between the test group and the control group

Question 15

What is a blind trial?

Answer 15

A clinical trial where the human subjects do not know if they are receiving the active treatment or the placebo

Question 16

What is a double blind trial?

Answer 16

A clinical trial where both the human subjects and the doctors do not know if they are receiving the active ingredient or the placebo

Question 17

What does the use of a double blind trial allow during a phase 3 clinical trial?

Answer 17

The elimination of bias

Question 18

What is randomisation during phase 3 clinical trial?

Answer 18

Where the details of gender, age and other details are entered into a computer and the computer puts each personal random into one of the two groups (test and control)

Question 19

What does the use of randomisation during a phase 3 clinical trial help to eliminate?

Answer 19

Bias

Question 20

How is experimental error during a phase 3 clinical trial reduced?

Answer 20

By using a very large sample of population and ensuring that both the test and control groups have similar people in them in terms of age, sex etc.

Question 21

Apart from reducing experimental error during a phase 3 clinical trial, why else is a large sample population required?

Answer 21

To allow the results obtained to be subjected to statistical analysis with confidence.