Clinical Trials of Vaccines and Drugs Flashcards
Why are vaccines and drugs
subjected to clinical trials?
To establish their safety and effectiveness before being licensed for use
Name three different design protocols used in clinical trials of vaccines and drugs
Randomised,
double blind
placebo-controlled
Describe a randomised protocol in
vaccine and drug testing and
explain its importance
groups in a randomized way to reduce bias in the distribution of characteristics such as age and gender
Describe a double-blind protocol used
in vaccine and drug testing and explain its importance
Neither the subjects nor the researchers know which group subjects are in to prevent biased interpretation of the results
Describe a placebo-controlled
protocol used in vaccine and drug
testing and explain its importance
One group of subjects receives the vaccine or drug while the other group receive a placebo control to ensure valid comparisons
Describe the size of groups used in
clinical trials of drugs and
vaccines and explain its importance
The size of groups must be suitable to
reduce the magnitude of experimental error
State why groups are compared at
the end of a clinical trial on drugs
or vaccines
To determine whether there are any
statistically significant differences between the groups