clinical trials of vaccines and drugs

Question 1

why are clinical trials carried out

Answer 1

establish their safety and effectiveness before being licensed for use.

Question 2

State the design of clinical trials

Answer 2

randomised, double-

blind and placebo-controlled protocols.

Question 3

Describe how trials are randomised and state its importance

Answer 3

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 4

Describe how trials are double-blind and state its importance

Answer 4

In a double-blind trial neither the subjects nor the researchers know which group subjects are in to prevent biased interpretation of the results. One group of subjects receives the vaccine or drug while the second group receives a placebo-control to ensure valid comparisons.

Question 5

Explain the importance of a large group size.

Answer 5

A large group size reduces experimental error and establishes statistical significance.

Question 6

Explain why the results are compared at the end of a trial

Answer 6

At the end of the trial, results from the two groups, which must be of a suitable size to
reduce the magnitude of experimental error, are compared to determine whether there are any statistically significant differences between the groups.