Higher Human Biology Unit 3 B Immunology KEY

Higher Human Biology Unit 3 B Immunology KEY AREA 4 B: Clinical Trials of Vaccines and Drugs

4 a ) Clinical Trials Vaccines and drugs are subjected to clinical trials to establish their safety and effectiveness before being licensed for use Clinical Trials involve testing on cells and animals in the lab first, and once protocols have been approved then testing on humans can take place During a clinical trial, then subjects are split into groups in a randomised way in which neither the subjects nor the researchers know which group they are in e. g. 2 groups (test group, control group)

4 b) Clinical Trial Design Placebo Effect One group of subjects are given the vaccine/drug while the 2 nd group are given a ‘placebo-control’ to ensure valid comparisons Double-blind Trial Neither the subjects nor the researchers know which group subjects are in to prevent biased interpretation of results Randomised Information about each individual (e. g. age, gender etc) is hidden, so groups are made randomly and not based on current health to eliminate bias

4 b) Clinical Trial Design Sample group size must be suitable to reduce experimental error and to establish statistical significance At the end of the trial results are compared to determine whethere any statistically significant differences between the groups

Clinical Trials of Vaccines and Drugs Questions: KEY AREA 4 B 1. Testing Your Knowledge 1 Page 335 Q 3 2. What you should know Page 345 Q 4 -6 3. Applying Knowledge and Skills Page 346 Q 1 -6 4. Quick Quiz