KA8 Clinical trials of vaccines and drugs

Question 1

Why are vaccines and drugs subjected to clinical trials?

Answer 1

To establish their safety and effectiveness before being licensed for use

Question 2

What are vaccines and drugs tested on before humans?

Answer 2

Stem cells and animals

Question 3

In phase 3 clinical trials, what two groups is the population split into?

Answer 3

The test group

The control group - no treatment

Question 4

What 3 things does the design of clinical trial involve?

Answer 4

Randomised
Double-blind
Placebo-controlled

Question 5

What does randomised mean?

Answer 5

Subjects in clinical trials are divided into groups in a randomised way to reduce bias in the distribution of characteristics such as age and gender

Question 6

What does double-blind mean?

Answer 6

In a double blind trial neither the subjects nor the researchers know which group subjects are in to prevent biased interpretation of the results

Question 7

What does placebo controlled mean?

Answer 7

One group of subjected receives the vaccine/ drug while the second group receives a placebo-control to ensure valid comparisons

Question 8

What happens at the end of the clinical trial?

Answer 8

Results from the two groups are compared to determine whether there are any statistically significant differences between the two groups

Question 9

Why must each group of participants be of a suitable size.

Answer 9

To reduce the magnitude of experimental error